Safety, Tolerability and Pharmacokinetics 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:
NCT01134562
First received: May 28, 2010
Last updated: August 31, 2011
Last verified: August 2011

May 28, 2010
August 31, 2011
August 2010
April 2011   (final data collection date for primary outcome measure)
Safety and tolerability of rising single doses of KAI-4169 by IV injection in hemodialysis subjects with secondary hyperparathyroidism [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01134562 on ClinicalTrials.gov Archive Site
  • Assess the effect of KAI-4169 on iPTH and serum calcium [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics of rising single doses of KAI-4169 by IV injection in hemodialysis subjects with secondary hyperparathyroidism [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Pharmacokinetics of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism
A Double-Blind, Randomized, Placebo-Controlled, Two-Period Crossover Study to Assess the Safety and Tolerability of Single Ascending Doses of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism

The purpose of this study is to characterize the safety and tolerability of single rising doses of KAI-4169 in hemodialysis subjects with secondary hyperparathyroidism.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hyperparathyroidism, Secondary
  • Drug: Saline
    Single IV injection
  • Drug: KAI-4169
    Single IV injection
  • Placebo Comparator: Placebo
    Subjects will be randomly assigned to receive either KAI-4169 or placebo
    Intervention: Drug: Saline
  • Experimental: KAI-4169
    Subjects will be randomly assigned to receive either KAI-4169 or placebo
    Intervention: Drug: KAI-4169
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects provides written informed consent.
  • iPTH at least 300 pg/mL (32 pmol/L) and no greater than 1200 pg/mL (127 pmol/L) and corrected calcium at least 9.0 mg/dL (2.25 mmol/L)
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT01134562
KAI-4169-002
No
KAI Pharmaceuticals
KAI Pharmaceuticals
Not Provided
Study Director: Gregory Bell, MD KAI Pharmaceuticals
KAI Pharmaceuticals
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP