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

• Sponsor: OPKO IP Holdings II, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00888069
• Collaborator: (none)
• Enrollment: 28
• Locations: 12
• Arms: 3
• Duration (Months): 7
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.3

Study Details

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).

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT [from 3 to 0 hours prior to dosing until 42 days post dosing]

Secondary Outcome Measures

1. To assess the safety and tolerability of CTAP101 capsules and injection [From signing of ICF (Day -35) through study completion (Day 42 post dosing)]

2. To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT. [From signing of ICF (Day -35) through study completion (Day 42 post dosing)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pivotal Research Centers	Peoria	Arizona	United States	85381
2	Research by Design	Evergreen Park	Illinois	United States	60805
3	Western New England Renal & Transplant Associates	Springfield	Massachusetts	United States	01107
4	Twin Cities Clinical Research	Brooklyn Center	Minnesota	United States	55430
5	DCI	Cincinnati	Ohio	United States	45206
6	MetroHealth Medical Center	Cleveland	Ohio	United States	44109-1998
7	Northeast Clinical Research	Allentown	Pennsylvania	United States	18103
8	Southeast Renal Research Institute	Chattanooga	Tennessee	United States	37404
9	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
10	Southwest Houston Research Ltd	Houston	Texas	United States	77099
11	Purity Dialysis Centers / Nephrology Associates	Delafield	Wisconsin	United States	53018
12	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: OPKO IP Holdings II, Inc.
• ClinicalTrials.gov Identifier: NCT00888069
• Other Study ID Numbers: CTAP101-CL-2004
• First Posted: Apr 24, 2009
• Last Update Posted: Sep 30, 2014
• Last Verified: Feb 1, 2010

• Keywords provided by OPKO IP Holdings II, Inc.: Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D; Hyperparathyroidism; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary

Study Results

No Results Posted as of Sep 30, 2014