Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder

NCT01414114 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: KAI-4169-00520120331
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).

Conditions

Secondary Hyperparathyroidism

Keywords

Clinical Trial, Phase 2; Renal Dialysis; Secondary Hyperparathyroidism; Chronic kidney disease-mineral and bone disorder; Parathyroid hormone

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period

  Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.

  Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)

Secondary Outcomes (4)

• Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period

  Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)

• Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period

  The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)

• Percent Change From Baseline in Corrected Calcium During the Efficacy Period

  Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)

• Percent Change From Baseline in Phosphorus During the Efficacy Period

  Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)

Study Arms (1)

Etelcalcetide

EXPERIMENTAL

Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.

Drug: Etelcalcetide

Interventions

Etelcalcetide DRUG

Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.

Also known as: KAI-4169, AMG 416, Parsabiv™

Etelcalcetide

Eligibility Criteria

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

You may qualify if:

• Subjects provides written informed consent
• Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL
• Hemoglobin ≥ 8.5 g/dL
• Serum transaminases (alanine transaminase \[ALT\], aspartate transaminase \[AST\]) less than 2.5 times the upper limit of normal
• Adequate hemodialysis three times per week

You may not qualify if:

• History or symptomatic ventricular dysrhythmias
• History of angina pectoris or congestive heart failure
• History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
• History of or treatment for seizure disorder within the last 12 months
• Postdialysis systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 90 mmHg
• Serum magnesium below the lower limit of normal at screening

Sponsors & Collaborators

• KAI Pharmaceuticals: lead

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Chronic Kidney Disease-Mineral and Bone Disorder

Interventions

etelcalcetide hydrochloride

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Amgen, Inc

866-572-6436

Study Officials

• Gregory Bell, MD

  KAI Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 11, 2011
• Study Start: December 5, 2011
• Primary Completion: May 21, 2012
• Study Completion: May 21, 2012
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-02