Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects
This study has been completed.
Sponsor:
KAI Pharmaceuticals
Information provided by (Responsible Party):
KAI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01414114
First received: August 9, 2011
Last updated: April 25, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of KAI-4169 in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis subjects with chronic kidney disease-mineral and bone disorder (CKD-MBD).
| Condition | Intervention | Phase |
|---|---|---|
|
Secondary Hyperparathyroidism |
Drug: KAI-4169 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single-arm, Open-label, Multicenter, Dose Titration Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects With Chronic Kidney Disease-Mineral and Bone Disorder |
Resource links provided by NLM:
Further study details as provided by KAI Pharmaceuticals:
Primary Outcome Measures:
- Percent change in iPTH from baseline during the efficacy period [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects with ≥ 30% reduction in iPTH from baseline during the efficacy period [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
- Proportion of subjects with iPTH ≤ 300 pg/mL during the efficacy period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Mean change in corrected calcium and phosphorus from baseline during the efficacy period [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 37 |
| Study Start Date: | December 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: KAI-4169 |
Drug: KAI-4169
KAI-4169 will be administered IV thrice weekly for 12 weeks. Dose will be titrated to effect.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 (ALT or SGPT, AST or SGOT) less than 2.5 times the upper limit of normal
- Adequate hemodialysis three times per week
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 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | KAI Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01414114 History of Changes |
| Other Study ID Numbers: | KAI-4169-005 |
| Study First Received: | August 9, 2011 |
| Last Updated: | April 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by KAI Pharmaceuticals:
|
Clinical Trial, Phase 2 Renal Dialysis Secondary Hyperparathyroidism Chronic kidney disease-mineral and bone disorder Parathyroid hormone |
Additional relevant MeSH terms:
|
Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Renal Insufficiency, Chronic |
Parathyroid Diseases Endocrine System Diseases Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 22, 2013