Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism
This study has been completed.
Sponsor:
KAI Pharmaceuticals
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
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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
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 May 23, 2013