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Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects

Primary Purpose

Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CTAP101 Capsules
CTAP101 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 great than or equal to 18 and less than or equal to 40 kg/m2
  • Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL
  • Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL
  • Adjusted serum total calcium value greater than 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 15 ng/mL and lower than 30 ng/mL
  • Hemoglobin level greater than or equal to 10 g/dL

Exclusion Criteria:

  • Has nephrotic range proteinuria
  • Has liver disease or significant hepatic dysfunction
  • Is taking Cytochrome P450 3A4 inhibitors or inducers
  • Has adult history of kidney stones and dysphagia
  • Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen
  • Currently on dialysis
  • Current serious illness such as cancer, HIV, cardiovascular event or hepatitis

Sites / Locations

  • Pivotal Research Centers
  • Research by Design
  • Western New England Renal & Transplant Associates
  • Twin Cities Clinical Research
  • DCI
  • MetroHealth Medical Center
  • Northeast Clinical Research
  • Southeast Renal Research Institute
  • Vanderbilt University Medical Center
  • Southwest Houston Research Ltd
  • Purity Dialysis Centers / Nephrology Associates
  • Gunderson Clinic Ltd.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low Dose CTAP101 Capsules

High Dose CTAP101 Capsules

CTAP101 Injection

Arm Description

CTAP101 Capsules, 450 mcg dose

CTAP101 Capsules, 900 mcg dose

IV injection, 448 mcg dose

Outcomes

Primary Outcome Measures

To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT

Secondary Outcome Measures

To assess the safety and tolerability of CTAP101 capsules and injection
To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT.

Full Information

First Posted
April 23, 2009
Last Updated
September 29, 2014
Sponsor
OPKO IP Holdings II, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00888069
Brief Title
Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects
Official Title
A Randomized, Open-Label, Single-Dose Pilot Study of Oral and i.v. CTAP101 Evaluating PK and Safety in Stage 3 and 4 CKD Subjects With Vitamin D Insufficiency and SHPT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (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 how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).

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 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose CTAP101 Capsules
Arm Type
Experimental
Arm Description
CTAP101 Capsules, 450 mcg dose
Arm Title
High Dose CTAP101 Capsules
Arm Type
Experimental
Arm Description
CTAP101 Capsules, 900 mcg dose
Arm Title
CTAP101 Injection
Arm Type
Experimental
Arm Description
IV injection, 448 mcg dose
Intervention Type
Drug
Intervention Name(s)
CTAP101 Capsules
Intervention Description
Single dose oral administration
Intervention Type
Drug
Intervention Name(s)
CTAP101 Injection
Intervention Description
single IV injection
Primary Outcome Measure Information:
Title
To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT
Time Frame
from 3 to 0 hours prior to dosing until 42 days post dosing
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability of CTAP101 capsules and injection
Time Frame
From signing of ICF (Day -35) through study completion (Day 42 post dosing)
Title
To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT.
Time Frame
From signing of ICF (Day -35) through study completion (Day 42 post dosing)

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 great than or equal to 18 and less than or equal to 40 kg/m2 Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL Adjusted serum total calcium value greater than 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 15 ng/mL and lower than 30 ng/mL Hemoglobin level greater than or equal to 10 g/dL Exclusion Criteria: Has nephrotic range proteinuria Has liver disease or significant hepatic dysfunction Is taking Cytochrome P450 3A4 inhibitors or inducers Has adult history of kidney stones and dysphagia Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen Currently on dialysis Current serious illness such as cancer, HIV, cardiovascular event or hepatitis
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
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Research by Design
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Western New England Renal & Transplant Associates
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Twin Cities Clinical Research
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
Facility Name
DCI
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
Facility Name
Northeast Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Southeast Renal Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Southwest Houston Research Ltd
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Purity Dialysis Centers / Nephrology Associates
City
Delafield
State/Province
Wisconsin
ZIP/Postal Code
53018
Country
United States
Facility Name
Gunderson Clinic Ltd.
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects

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