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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyperparathyroidism, Secondary
 Drug: Saline
Drug: KAI-4169
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: August 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects will be randomly assigned to receive either KAI-4169 or placebo
 Drug: Saline
Single IV injection
Experimental: KAI-4169
Subjects will be randomly assigned to receive either KAI-4169 or placebo
 Drug: KAI-4169
Single IV injection

  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.
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134562

Locations
United States, California
Cypress, California, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Texas
Houston, Texas, United States
Australia, Queensland
Brisbane, Queensland, Australia
Australia, Victoria
Melbourne, Victoria, Australia
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: NCT01134562     History of Changes
Other Study ID Numbers: KAI-4169-002
Study First Received: May 28, 2010
Last Updated: August 31, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by KAI Pharmaceuticals:
Clinical Trial, Phase 1
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