Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

NCT02102204 | Completed Phase 3 Results

• 3 other identifiers: 201302132013-004136-30KAI-4169
• Study Type: interventional
• Target: 902
• Locations: 23 countries
• Sites: 223

Brief Summary

This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

Conditions

Hyperparathyroidism, Secondary

Keywords

Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  A serious adverse event is an AE that met at least 1 of the following criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event. The relationship of each AE to study treatment was assessed by the investigator. The following AE grading scale was used: Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable.

  From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.

Secondary Outcomes (5)

• Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal

  Months 6, 12, and 18

• Percentage of Participants With Serum Phosphorus ≤ the ULN

  Months 6, 12, and 18

• Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL

  From day 1 to months 6, 12, and 18

• Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters

  Baseline to end of treatment; median duration of treatment was 563 days.

• Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies

  Baseline and every 6 months (up to 24 months)

Study Arms (1)

Etelcalcetide

EXPERIMENTAL

Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.

Drug: Etelcalcetide

Interventions

Etelcalcetide DRUG

Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.

Also known as: KAI-4169, AMG 416, Parasabiv

Etelcalcetide

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided informed consent prior to initiation of any study-specific activities/procedures
• Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)
• Female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study
• Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months

You may not qualify if:

• Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies)
• Subject has known sensitivity to any of the products or components to be administered during dosing
• Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study
• Subject is receiving dialysis prescription dialysate calcium concentration \< 2.25 mEq/L
• Subject is pregnant or nursing

Sponsors & Collaborators

• Amgen: lead

Study Sites (228)

Research Site

Birmingham, Alabama, 35211, United States

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Alhambra, California, 91801, United States

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Azusa, California, 91702, United States

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Bakersfield, California, 93308, United States

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Cudahy, California, 90201, United States

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Granada Hills, California, 91344, United States

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Los Angeles, California, 90022, United States

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Los Angeles, California, 90048, United States

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Northridge, California, 91324, United States

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Riverside, California, 92501, United States

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Simi Valley, California, 93065, United States

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Vacaville, California, 95687, United States

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Whittier, California, 90603, United States

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Aurora, Colorado, 80045, United States

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Westminster, Colorado, 80031, United States

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Stamford, Connecticut, 06902, United States

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Miami, Florida, 33150, United States

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Ocala, Florida, 34471, United States

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Pembroke Pines, Florida, 33028, United States

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Tampa, Florida, 33614, United States

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Augusta, Georgia, 30909, United States

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Dublin, Georgia, 31021, United States

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Meridian, Idaho, 83642, United States

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Highland Park, Illinois, 60035, United States

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Merrillville, Indiana, 46410, United States

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Michigan City, Indiana, 46360, United States

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Wichita, Kansas, 67214-2998, United States

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Baton Rouge, Louisiana, 70808, United States

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Springfield, Massachusetts, 01107, United States

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Detroit, Michigan, 48236, United States

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Pontiac, Michigan, 48341, United States

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Brookhaven, Mississippi, 39601, United States

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Columbus, Mississippi, 39705, United States

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Gulfport, Mississippi, 39501, United States

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Tupelo, Mississippi, 38801, United States

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Kansas City, Missouri, 64111, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89106, United States

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Reno, Nevada, 89511, United States

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Eatontown, New Jersey, 07724, United States

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Voorhees Township, New Jersey, 08043, United States

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Brooklyn, New York, 11235, United States

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College Point, New York, 11356, United States

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Great Neck, New York, 11021, United States

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Mineola, New York, 11501, United States

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Rosedale, New York, 11422, United States

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The Bronx, New York, 10461, United States

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Yonkers, New York, 10704, United States

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Durham, North Carolina, 27704, United States

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New Bern, North Carolina, 28562, United States

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Wilmington, North Carolina, 28401, United States

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Cincinnati, Ohio, 45267, United States

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Columbus, Ohio, 43215, United States

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Oklahoma City, Oklahoma, 73116, United States

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Bethlehem, Pennsylvania, 18017, United States

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Philadelphia, Pennsylvania, 19106, United States

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Columbia, South Carolina, 29203, United States

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Chattanooga, Tennessee, 37408, United States

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Knoxville, Tennessee, 37923, United States

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Arlington, Texas, 76015, United States

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Edinburg, Texas, 78539, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Burlington, Vermont, 05401, United States

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Fairfax, Virginia, 22033, United States

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Hampton, Virginia, 23666, United States

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Mechanicsville, Virginia, 23116, United States

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Bluefield, West Virginia, 24701, United States

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Liverpool, New South Wales, 2170, Australia

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Westmead, New South Wales, 2145, Australia

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Brisbane, Queensland, 4102, Australia

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Adelaide, South Australia, 5000, Australia

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Clayton, Victoria, 3168, Australia

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Prahan, Victoria, 3004, Australia

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Feldkirch, 6807, Austria

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Graz, 8036, Austria

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Linz, 4020, Austria

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Vienna, 1090, Austria

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Vienna, 1220, Austria

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Aalst, 9300, Belgium

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Baudour, 7331, Belgium

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Bonheiden, 2820, Belgium

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Brussels, 1020, Belgium

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Brussels, 1200, Belgium

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Hasselt, 3500, Belgium

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Kortrijk, 8500, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Roeselare, 8800, Belgium

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Tournai, 7500, Belgium

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Edmonton, Alberta, T6G 2B7, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Brampton, Ontario, L6R 3J7, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Hradec Králové, 500 05, Czechia

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Nový Jičín, 741 01, Czechia

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Pilsen, 301 00, Czechia

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Prague, 140 21, Czechia

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Prague, 169 00, Czechia

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Praha 4 - Nusle, 140 00, Czechia

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Slavkov u Brna, 684 01, Czechia

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Ústí nad Orlicí, 562 18, Czechia

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Copenhagen, 2100, Denmark

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Fredericia, 7000, Denmark

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Caen, 14000, France

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La Tronche, 38701, France

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Lille, 59800, France

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Marseille, 13253, France

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Paris, 75011, France

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Paris, 75014, France

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Reims, 51092, France

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Saint-Ouen, 93400, France

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Saint-Priest-en-Jarez, 42270, France

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Aachen, 52074, Germany

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Berlin, 12053, Germany

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Hamburg, 22297, Germany

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Langenhagen, 30853, Germany

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Minden, 32429, Germany

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München, 81675, Germany

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Villingen-Schwenningen, 78052, Germany

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Wiesbaden, 65191, Germany

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Zwickau, 08060, Germany

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Alexandroupoli, 68100, Greece

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Larissa, 41110, Greece

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Nikaia, Piraeus, 18454, Greece

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Pátrai, 26500, Greece

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Thessaloniki, 54636, Greece

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Baja, 6500, Hungary

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Budapest, 1106, Hungary

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Esztergom, 2500, Hungary

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Győr, 9023, Hungary

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Kaposvár, 7400, Hungary

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Kistarcsa, 2143, Hungary

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Miskolc, 3526, Hungary

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Pécs, 7624, Hungary

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Pécs, 7633, Hungary

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Székesfehérvár, 8000, Hungary

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Szigetvár, 7900, Hungary

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Zalaegerszeg, 8900, Hungary

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Ashkelon, 78278, Israel

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Jerusalem, 91120, Israel

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Tel Aviv, 64239, Israel

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Tel Litwinsky, 52621, Israel

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Ẕerifin, 70300, Israel

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Ancona, 60126, Italy

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Florence, 50139, Italy

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Genova, 16132, Italy

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Lecco, 23900, Italy

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Lucca, 55100, Italy

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Milan, 20122, Italy

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Pavia, 27100, Italy

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Pisa, 56126, Italy

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Pordenone, 33170, Italy

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Verona, 37126, Italy

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Riga, 1001, Latvia

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Alytus, 63351, Lithuania

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Kaunas, 50009, Lithuania

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Kaunas, 50169, Lithuania

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Ukmerge, 20184, Lithuania

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Rotterdam, 3079 DZ, Netherlands

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Venlo, 5912 BL, Netherlands

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Hamilton, 3240, New Zealand

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Gdansk, 80-952, Poland

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Golub-Dobrzyń, 87-400, Poland

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Katowice, 40-027, Poland

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Krakow, 31-501, Poland

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Lodz, 90-153, Poland

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Poznan, 60-355, Poland

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Poznan, 61-696, Poland

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Sieradz, 98-200, Poland

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Wadowice, 34-100, Poland

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Warsaw, 02-097, Poland

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Warsaw, 02-507, Poland

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Zabrze, 41-800, Poland

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Zamość, 87-100, Poland

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Żyrardów, 96-300, Poland

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Almada, 2800-455, Portugal

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Aveiro, 3800-266, Portugal

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Forte Da Casa, 2625-437, Portugal

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Guimarães, 4810-273, Portugal

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Lisbon, 1750-130, Portugal

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Santo Tirso, 4780-383, Portugal

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Setúbal, 2900-655, Portugal

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Vila Franca de Xira, 2600-076, Portugal

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Mitishi, 141009, Russia

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Moscow, 129327, Russia

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Petrozavodsk, 185019, Russia

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Saint Petersburg, 191104, Russia

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Saint Petersburg, 193318, Russia

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Saint Petersburg, 195067, Russia

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Saint Petersburg, 195257, Russia

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Saint Petersburg, 196247, Russia

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Saint Petersburg, 197110, Russia

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Saint Petersburg, 198510, Russia

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Yaroslavl, 150062, Russia

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Córdoba, Andalusia, 14004, Spain

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Santander, Cantabria, 39008, Spain

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Barcelona, Catalonia, 08003, Spain

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Barcelona, Catalonia, 08025, Spain

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Barcelona, Catalonia, 08035, Spain

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Barcelona, Catalonia, 08036, Spain

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Lleida, Catalonia, 25198, Spain

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Badajoz, Extremadura, 06080, Spain

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Majadahonda, Madrid, 28222, Spain

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Pamplona, Navarre, 31008, Spain

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Torrevieja, Valencia, 03186, Spain

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Valencia, Valencia, 46017, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Karlstad, 651 85, Sweden

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Stockholm, 118 67, Sweden

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Stockholm, 141 86, Sweden

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Trollhättan, 467 85, Sweden

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Uppsala, 751 85, Sweden

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Aarau, 5001, Switzerland

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Bern, 3010, Switzerland

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Geneva, 1211, Switzerland

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Lausanne, 1003, Switzerland

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Lausanne, 1011, Switzerland

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Locarno, 6600, Switzerland

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Zurich, 8091, Switzerland

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Ankara, 06230, Turkey (Türkiye)

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Ankara, 06810, Turkey (Türkiye)

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Istanbul, 34371, Turkey (Türkiye)

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Istanbul, 34890, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

etelcalcetide hydrochloride

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: April 2, 2014
• Study Start: March 25, 2014
• Primary Completion: November 4, 2016
• Study Completion: June 26, 2017
• Last Updated: November 17, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-10

Locations

AU (6); IL (5); RU (11); CA (6); FR (9); LI (4); TU (5); PT (8); HU (12); NL (2); LA (1); DE (9); NZ (1); CH (7); GR (5); IT (10); ES (14); SE (5); BE (11); CZ (8); DK (2); US (68); PL (14)