Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KAI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01254565
First received: December 3, 2010
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of KAI-4169 in hemodialysis subjects for the treatment of secondary hyperparathyroidism.


Condition Intervention Phase
Secondary Hyperparathyroidism
Drug: KAI-4169
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Multiple Ascending Dose Study to Assess the Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:
  • Percent change from baseline in mean intact parathyroid hormone (iPTH) levels [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with ≥ 30% decrease from baseline in iPTH [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Percent change from baseline in mean serum corrected calcium and phosphate [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KAI-4169 Drug: KAI-4169
Subjects will be randomly assigned to receive either KAI-4169 or placebo as an intravenous bolus three times weekly with hemodialysis for four weeks
Placebo Comparator: Placebo Drug: Placebo
Subjects will be randomly assigned to receive either KAI-4169 or placebo as an intravenous bolus three times weekly with hemodialysis for four weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject provides written informed consent.
  • Intact PTH at least 350 pg/mL.
  • Corrected calcium at least 9.0 mg/dL.
  • Hemoglobin at least 9.0 g/dL.
  • Adequate hemodialysis three times per week.
  • Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests.

Exclusion Criteria:

  • 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.
  • Recent (3 months) parathyroidectomy.
  • Serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater than two times the upper limit of normal at screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254565

Locations
United States, California
Azusa, California, United States, 91702
Costa Mesa, California, United States, 92626
Lynwood, California, United States, 90262
Riverside, California, United States, 92505
San Diego, California, United States, 92123
United States, Colorado
Denver, Colorado, United States, 80218
United States, Georgia
Macon, Georgia, United States, 31217
United States, Louisiana
Shreveport, Louisiana, United States, 71101
United States, Minnesota
Brooklyn Center, Minnesota, United States, 55430
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
Houston, Texas, United States, 77099
Houston, Texas, United States, 77004
United States, Virginia
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
KAI Pharmaceuticals
Investigators
Study Director: Gregory Bell, MD KAI Pharmaceuticals
  More Information

No publications provided

Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01254565     History of Changes
Other Study ID Numbers: KAI-4169-003
Study First Received: December 3, 2010
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by KAI Pharmaceuticals:
Clinical Trial, Phase 2
Renal Dialysis
Secondary Hyperparathyroidism
Parathyroid hormone

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 01, 2014