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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc. ( OPKO IP Holdings II, Inc. )
ClinicalTrials.gov Identifier:
NCT00888069
First received: April 23, 2009
Last updated: September 29, 2014
Last verified: February 2010
  Purpose

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).


Condition Intervention Phase
Chronic Kidney Disease
Secondary Hyperparathyroidism
Chronic Renal Insufficiency
Chronic Renal Failure
Drug: CTAP101 Capsules
Drug: CTAP101 Injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by OPKO Health, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose CTAP101 Capsules
CTAP101 Capsules, 450 mcg dose
Drug: CTAP101 Capsules
Single dose oral administration
Experimental: High Dose CTAP101 Capsules
CTAP101 Capsules, 900 mcg dose
Drug: CTAP101 Capsules
Single dose oral administration
Experimental: CTAP101 Injection
IV injection, 448 mcg dose
Drug: CTAP101 Injection
single IV injection

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888069

Locations
United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
United States, Illinois
Research by Design
Evergreen Park, Illinois, United States, 60805
United States, Massachusetts
Western New England Renal & Transplant Associates
Springfield, Massachusetts, United States, 01107
United States, Minnesota
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States, 55430
United States, Ohio
DCI
Cincinnati, Ohio, United States, 45206
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109-1998
United States, Pennsylvania
Northeast Clinical Research
Allentown, Pennsylvania, United States, 18103
United States, Tennessee
Southeast Renal Research Institute
Chattanooga, Tennessee, United States, 37404
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Southwest Houston Research Ltd
Houston, Texas, United States, 77099
United States, Wisconsin
Purity Dialysis Centers / Nephrology Associates
Delafield, Wisconsin, United States, 53018
Gunderson Clinic Ltd.
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
OPKO IP Holdings II, Inc.
Investigators
Study Director: Joel Melnick, MD OPKO Renal
  More Information

No publications provided

Responsible Party: OPKO Health, Inc. ( OPKO IP Holdings II, Inc. )
ClinicalTrials.gov Identifier: NCT00888069     History of Changes
Other Study ID Numbers: CTAP101-CL-2004
Study First Received: April 23, 2009
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by OPKO Health, Inc.:
Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Vitamin D
Hyperparathyroidism
Renal Insufficiency, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Endocrine System Diseases
Parathyroid Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014