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

Sponsor

OPKO IP Holdings II, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00742716

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

3.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Secondary Hyperparathyroidism Chronic Renal Insufficiency Chronic Renal Failure	Drug: CTA018 Injection	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTA018 Injection low dose Low dose IV 3 times a week for 4 weeks	Drug: CTA018 Injection Comparison of different dosages of drug
Experimental: CTA018 Injection low to mid dose low to mid dose IV 3 times a week for 4 weeks	Drug: CTA018 Injection Comparison of different dosages of drug
Experimental: CTA018 Injection mid to high dose mid to high dose IV 3 times a week for 4 weeks	Drug: CTA018 Injection Comparison of different dosages of drug
Experimental: CTA018 Injection high dose high dose IV 3 times a week for 4 weeks	Drug: CTA018 Injection Comparison of different dosages of drug

Outcome Measures

Primary Outcome Measures

To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection [Day 1 and 12 of each dose level]
To investigate the safety of CTA018 Injection [Throughout the study]

Secondary Outcome Measures

To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection [Throughout the study]
To determine the efficacy of CTA018 Injection to reduce serum iPTH [Throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pines Clinical Research, Inc.	Pembroke Pines	Florida	United States	33028
2	Boise Kidney and Hypertension Institute	Meridian	Idaho	United States	83642
3	Western New England Renal & Transplant Associates (WNERTA)	Springfield	Massachusetts	United States	01107-1121
4	Southeast Renal Research Institute	Chattanooga	Tennessee	United States	37404
5	U.S. Renal Care	Fort Worth	Texas	United States	76105
6	Capital District Heatlth Authority: Centre for Clinical Research	Halifax	Nova Scotia	Canada	B3H 1V8
7	St. Joseph's Health Care London	London	Ontario	Canada	N6A 4V2
8	St. Michael's Hospital	Toronto	Ontario	Canada	M5N 1W8
9	Humber River Regional Hospital	Weston	Ontario	Canada	M9N 1N8
10	Hôpital Charles-Lemoyne	Greenfield Park	Quebec	Canada	J4V 2H1
11	Hôpital du Sacré-Coeur de Montréal	Montreal	Quebec	Canada	H4J 1C5
12	Hospital de Verdun	Verdun	Quebec	Canada	H4G 2A3