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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888069
• Other study ID #: CTAP101-CL-2004
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2009
• Last updated: September 29, 2014
• Start date: May 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2010
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Renal Failure
• Chronic Renal Insufficiency
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• CTAP101 Capsules
Single dose oral administration
• CTAP101 Injection
single IV injection

Locations

Country	Name	City	State
United States	Northeast Clinical Research	Allentown	Pennsylvania
United States	Twin Cities Clinical Research	Brooklyn Center	Minnesota
United States	Southeast Renal Research Institute	Chattanooga	Tennessee
United States	DCI	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Purity Dialysis Centers / Nephrology Associates	Delafield	Wisconsin
United States	Research by Design	Evergreen Park	Illinois
United States	Southwest Houston Research Ltd	Houston	Texas
United States	Gunderson Clinic Ltd.	La Crosse	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Pivotal Research Centers	Peoria	Arizona
United States	Western New England Renal & Transplant Associates	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
OPKO IP Holdings II, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess the safety and tolerability of CTAP101 capsules and injection		From signing of ICF (Day -35) through study completion (Day 42 post dosing)	Yes
Secondary	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)	No