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

Secondary Hyperparathyroidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414114
• Other study ID #: KAI-4169-005
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2011
• Last updated: July 8, 2015
• Start date: December 2011
• Est. completion date: August 2012

Study information

• Verified date: July 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• KAI-4169
KAI-4169 will be administered IV thrice weekly for 12 weeks. Dose will be titrated to effect.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KAI Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in iPTH from baseline during the efficacy period		Baseline, 12 weeks	No
Secondary	Proportion of subjects with = 30% reduction in iPTH from baseline during the efficacy period		Baseline, 12 weeks	No
Secondary	Proportion of subjects with iPTH = 300 pg/mL during the efficacy period		12 weeks	No
Secondary	Mean change in corrected calcium and phosphorus from baseline during the efficacy period		Baseline, 12 weeks	Yes