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

Primary Purpose

Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CTA018 Injection
Sponsored by
OPKO IP Holdings II, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Renal Insufficiency, Chronic, Kidney Diseases, Kidney Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pines Clinical Research, Inc.
  • Boise Kidney and Hypertension Institute
  • Western New England Renal & Transplant Associates (WNERTA)
  • Southeast Renal Research Institute
  • U.S. Renal Care
  • Capital District Heatlth Authority: Centre for Clinical Research
  • St. Joseph's Health Care London
  • St. Michael's Hospital
  • Humber River Regional Hospital
  • Hôpital Charles-Lemoyne
  • Hôpital du Sacré-Coeur de Montréal
  • Hospital de Verdun

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

CTA018 Injection low dose

CTA018 Injection low to mid dose

CTA018 Injection mid to high dose

CTA018 Injection high dose

Arm Description

Low dose IV 3 times a week for 4 weeks

low to mid dose IV 3 times a week for 4 weeks

mid to high dose IV 3 times a week for 4 weeks

high dose IV 3 times a week for 4 weeks

Outcomes

Primary Outcome Measures

To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection
To investigate the safety of CTA018 Injection

Secondary Outcome Measures

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

Full Information

First Posted
August 26, 2008
Last Updated
October 30, 2014
Sponsor
OPKO IP Holdings II, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00742716
Brief Title
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO IP Holdings II, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
Keywords
Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Renal Insufficiency, Chronic, Kidney Diseases, Kidney Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTA018 Injection low dose
Arm Type
Experimental
Arm Description
Low dose IV 3 times a week for 4 weeks
Arm Title
CTA018 Injection low to mid dose
Arm Type
Experimental
Arm Description
low to mid dose IV 3 times a week for 4 weeks
Arm Title
CTA018 Injection mid to high dose
Arm Type
Experimental
Arm Description
mid to high dose IV 3 times a week for 4 weeks
Arm Title
CTA018 Injection high dose
Arm Type
Experimental
Arm Description
high dose IV 3 times a week for 4 weeks
Intervention Type
Drug
Intervention Name(s)
CTA018 Injection
Intervention Description
Comparison of different dosages of drug
Primary Outcome Measure Information:
Title
To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection
Time Frame
Day 1 and 12 of each dose level
Title
To investigate the safety of CTA018 Injection
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection
Time Frame
Throughout the study
Title
To determine the efficacy of CTA018 Injection to reduce serum iPTH
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Melnick, MD
Organizational Affiliation
OPKO Renal
Official's Role
Study Director
Facility Information:
Facility Name
Pines Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Boise Kidney and Hypertension Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Western New England Renal & Transplant Associates (WNERTA)
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107-1121
Country
United States
Facility Name
Southeast Renal Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
U.S. Renal Care
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76105
Country
United States
Facility Name
Capital District Heatlth Authority: Centre for Clinical Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V8
Country
Canada
Facility Name
St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5N 1W8
Country
Canada
Facility Name
Humber River Regional Hospital
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Hôpital Charles-Lemoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Hospital de Verdun
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4G 2A3
Country
Canada

12. IPD Sharing Statement

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

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