Clinical trial NCT00888069: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT
timeFrame: from 3 to 0 hours prior to dosing until 42 days post dosing
Secondary outcomes:
measure: To assess the safety and tolerability of CTAP101 capsules and injection
timeFrame: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
measure: To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT.
timeFrame: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Evergreen Park
country: United States
facility: Research by Design
state: Illinois
city: Springfield
country: United States
facility: Western New England Renal & Transplant Associates
state: Massachusetts
city: Brooklyn Center
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Cincinnati
country: United States
facility: DCI
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Allentown
country: United States
facility: Northeast Clinical Research
state: Pennsylvania
city: Chattanooga
country: United States
facility: Southeast Renal Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Southwest Houston Research Ltd
state: Texas
city: Delafield
country: United States
facility: Purity Dialysis Centers / Nephrology Associates
state: Wisconsin
city: La Crosse
country: United States
facility: Gunderson Clinic Ltd.
state: Wisconsin
Study officials:
affiliation: OPKO Renal
name: Joel Melnick, MD
role: STUDY_DIRECTOR
References: