Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects

This study has been completed.
Sponsor:
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
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414114

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: 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 April 22, 2014