Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

NCT00975000 | Completed Phase 3 Results

• 1 other identifier: 20062007
• Study Type: interventional
• Target: 114
• Locations: 10 countries
• Sites: 50

Brief Summary

Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant.

Conditions

Chronic Allograft Nephropathy; Chronic Kidney Disease; Chronic Renal Failure; Disordered Mineral Metabolism; End Stage Renal Disease; Hyperparathyroidism; Hypophosphatemia; Kidney Disease; Kidney Transplantation; Post Renal Transplantation

Keywords

Intervention; Cinacalcet; Sensipar; Mimpara; hyperparathyroidism; calcium; osteodystrophy; hypercalcemia; renal; transplant; acute rejection; kidney transplant failure; hypophosphatemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)

  Weeks 21 to 26 (EAP)

Secondary Outcomes (8)

• Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck

  Baseline and Week 52

• Change From Baseline to the EAP in Mean Serum Phosphorus

  Baseline and the EAP (mean of Weeks 22, 24, and 26)

• Change From Baseline to Week 52 in eGFR

  Baseline and Week 52

• Change From Baseline to the EAP in Corrected Total Calcium

  Baseline and the EAP (mean of Weeks 22, 24, and 26)

• Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)

  Baseline and the EAP (mean of Weeks 22, 24, and 26)

Study Arms (2)

Cinacalcet

EXPERIMENTAL

Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parthyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.

Drug: Cinacalcet

Placebo

PLACEBO COMPARATOR

Participants received placebo orally once daily for 52 weeks.

Drug: Placebo

Interventions

Cinacalcet DRUG

Possible sequential doses are 30, 60, 90, 120, and 180 mg.

Also known as: Mimpara, Sensipar

Cinacalcet

Placebo DRUG

Administered orally following the same dosing regimen as the experimental arm.

Placebo

Eligibility Criteria

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

You may qualify if:

• Received a kidney transplant ≥ 9 weeks at time of Screening and ≤ 24 months before first dose
• May be the first kidney transplant or a repeat kidney transplant.
• Subjects with a functional, stable kidney transplant, defined as MDRD estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² (chromic kidney disease stage 3 or better) at Screening.
• Men or women ≥ 18 years at the start of Screening (ie, time of informed consent).
• Corrected total serum calcium \> 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2 values in Screening period.
• iPTH \> 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen 1 or Screen 2).

You may not qualify if:

• Received cinacalcet therapy post-transplant for more than 14 days cumulatively post-transplant. If cinacalcet therapy was received for a total of 14 days or less post-transplant, there must be a 4-week washout before subject is eligible for screening (Note: This does not exclude pre-transplant use of cinacalcet).
• Anticipated parathyroidectomy within 6 to12 months after Randomization.
• Ongoing therapy with bisphosphonates or use within 6 months prior to Screening.
• Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites or analogues) or use within 30 days prior to Screening.
• Ongoing use of calcium supplements or use within 30 days prior to Screening.
• Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30 days prior to Screening.
• Ongoing use of a thiazide diuretic.
• Subjects with a history of seizures who had a seizure within the 3 months prior to Randomization, which required adjustments to the seizure medication.
• Acute Kidney Injury (AKI) or renal biopsy within 6 weeks prior to Screening, unless it is an institutional protocol-driven biopsy.

Sponsors & Collaborators

• Amgen: lead

Study Sites (51)

Research Site

Phoenix, Arizona, 85012, United States

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Tempe, Arizona, 85284, United States

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San Francisco, California, 94143, United States

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Aurora, Colorado, 80045, United States

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Gainesville, Florida, 32610, United States

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Atlanta, Georgia, 30322, United States

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Chicago, Illinois, 60637, United States

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Evanston, Illinois, 60201, United States

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Springfield, Massachusetts, 01107, United States

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Detroit, Michigan, 48202, United States

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New York, New York, 10032, United States

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Bethlehem, Pennsylvania, 18017, United States

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Nashville, Tennessee, 37232, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77030, United States

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Camperdown, New South Wales, 2050, Australia

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Westmead, New South Wales, 2145, Australia

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Woodville South, South Australia, 5011, Australia

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Parkville, Victoria, 3050, Australia

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Vienna, 1090, Austria

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Calgary, Alberta, T2N 2T9, Canada

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Vancouver, British Columbia, V6Z 1Y6, Canada

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London, Ontario, N6A 5A5, Canada

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Ottawa, Ontario, K1H 7W9, Canada

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Toronto, Ontario, M5C 2T2, Canada

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Bordeaux, 33076, France

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Montpellier, 34295, France

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Nantes, 44093, France

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Paris, 75743, France

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Toulouse, 31403, France

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Berlin, 13353, Germany

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Kiel, 24105, Germany

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Genova, 16132, Italy

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Milan, 20122, Italy

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Padua, 35128, Italy

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Gdansk, 80-952, Poland

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Katowice, 40-027, Poland

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Lodz, 90-153, Poland

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Poznan, 60-539, Poland

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Szczecin, 70-111, Poland

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Málaga, AndalucÃ-a, 29010, Spain

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Barcelona, Cataluña, 08025, Spain

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Barcelona, Cataluña, 08036, Spain

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L'Hospitalet de Llobregat, Cataluña, 08907, Spain

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Madrid, 28041, Spain

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Bern, 3010, Switzerland

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Geneva, 1211, Switzerland

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Zurich, 8091, Switzerland

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Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hyperparathyroidism; Hypophosphatemia; Kidney Diseases; Hypercalcemia

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parathyroid Diseases; Endocrine System Diseases; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: December 3, 2009
• Primary Completion: September 13, 2012
• Study Completion: April 16, 2013
• Last Updated: October 17, 2018
• Results First Posted: January 29, 2016

Record last verified: 2018-09

Locations

CA (5); AU (4); FR (5); DE (2); ES (5); PL (5); IT (3); BE (3); US (15); CH (3)