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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014