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

Phase 1

Completed

• Conditions: Chronic Renal Insufficiency; Chronic Renal Failure; Chronic Kidney Disease; Secondary Hyperparathyroidism
• Interventions: Drug: CTAP101 Capsules; Drug: CTAP101 Injection

• Registration Number: NCT00888069
• Lead Sponsor: OPKO IP Holdings II, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Study Start: 2009-05
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Status Verified: 2010-02
• Last Update Submitted: 2014-09-29
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose CTAP101 Capsules	CTAP101 Capsules	CTAP101 Capsules, 900 mcg dose
Low Dose CTAP101 Capsules	CTAP101 Capsules	CTAP101 Capsules, 450 mcg dose
CTAP101 Injection	CTAP101 Injection	IV injection, 448 mcg dose

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
To assess the safety and tolerability of CTAP101 capsules and injection	From signing of ICF (Day -35) through study completion (Day 42 post dosing)

Trial Locations

Locations (12)

Pivotal Research Centers; 🇺🇸 Peoria, Arizona, United States

Research by Design; 🇺🇸 Evergreen Park, Illinois, United States

Western New England Renal & Transplant Associates; 🇺🇸 Springfield, Massachusetts, United States

Twin Cities Clinical Research; 🇺🇸 Brooklyn Center, Minnesota, United States

DCI; 🇺🇸 Cincinnati, Ohio, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Northeast Clinical Research; 🇺🇸 Allentown, Pennsylvania, United States

Southeast Renal Research Institute; 🇺🇸 Chattanooga, Tennessee, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Southwest Houston Research Ltd; 🇺🇸 Houston, Texas, United States

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