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

Secondary Hyperparathyroidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254565
• Other study ID #: KAI-4169-003
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2010
• Last updated: September 3, 2015
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: September 2015
• Source: KAI Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• KAI-4169
Subjects will be randomly assigned to receive KAI-4169 as an intravenous bolus three times weekly with hemodialysis for four weeks
• Placebo
Subjects will be randomly assigned to receive placebo formulation as an intravenous bolus three times weekly with hemodialysis for four weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KAI Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in mean intact parathyroid hormone (iPTH) levels		Baseline and Week 4	No
Secondary	Proportion of subjects with = 30% decrease from baseline in iPTH		Baseline and Week 4	No
Secondary	Percent change from baseline in mean serum corrected calcium and phosphate		Baseline and Week 4	No