Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

An Open Label, Four Week, Dose Escalating Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Study of CTA018 Injection in Subjects With Stage 5 Chronic Kidney Disease With Secondary Hyperparathyroidism on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742716
• Other study ID #: CTA018-CL-2002
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2008
• Last updated: October 30, 2014
• Start date: October 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2011
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. This study will also investigate the safety and effects of different strengths of CTA018, on parathyroid hormone (PTH) levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Body mass index between 18 and 35

• On maintenance hemodialysis three times per week

• Serum iPTH value greater than or equal to 300 pg/mL and lower than or equal to 1000 pg/mL

• Adjusted or total serum calcium value greater than or equal to 8.4 mg/dL and lower than 10.0 mg/dL

• Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL

• Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL

• Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and the length of study

Exclusion Criteria:

• On bisphosphonates for at least three months prior to first dose of Study Drug

• Currently taking cytochrome P450 3A inhibitors and/or inducers

• Abnormal liver functions

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Renal Failure
• Chronic Renal Insufficiency
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Kidney Failure, Chronic
• Neoplasm Metastasis
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• CTA018 Injection
Comparison of different dosages of drug

Locations

Country	Name	City	State
Canada	Hôpital Charles-Lemoyne	Greenfield Park	Quebec
Canada	Capital District Heatlth Authority: Centre for Clinical Research	Halifax	Nova Scotia
Canada	St. Joseph's Health Care London	London	Ontario
Canada	Hôpital du Sacré-Coeur de Montréal	Montreal	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Hospital de Verdun	Verdun	Quebec
Canada	Humber River Regional Hospital	Weston	Ontario
United States	Southeast Renal Research Institute	Chattanooga	Tennessee
United States	U.S. Renal Care	Fort Worth	Texas
United States	Boise Kidney and Hypertension Institute	Meridian	Idaho
United States	Pines Clinical Research, Inc.	Pembroke Pines	Florida
United States	Western New England Renal & Transplant Associates (WNERTA)	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
OPKO IP Holdings II, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection		Day 1 and 12 of each dose level	No
Primary	To investigate the safety of CTA018 Injection		Throughout the study	Yes
Secondary	To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection		Throughout the study	No
Secondary	To determine the efficacy of CTA018 Injection to reduce serum iPTH		Throughout the study	No