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

ClinicalTrials.gov ID: NCT00888069

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT00888069
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: OPKO IP Holdings II, Inc.; Industry
Enrollment: 28 participants

Conditions and interventions

Conditions

Interventions

CTAP101 Capsules Drug
CTAP101 Injection Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 80 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 2009 (Type not available)
Primary completion: Nov 2009 (Actual)
Completion: Dec 2009 (Actual)
Last update posted: Sep 30, 2014

2009

United States locations

U.S. sites: 12
U.S. states: 9
U.S. cities: 12

Facility	City	State	ZIP	Site status
Pivotal Research Centers	Peoria	Arizona	85381	—
Research by Design	Evergreen Park	Illinois	60805	—
Western New England Renal & Transplant Associates	Springfield	Massachusetts	01107	—
Twin Cities Clinical Research	Brooklyn Center	Minnesota	55430	—
DCI	Cincinnati	Ohio	45206	—
MetroHealth Medical Center	Cleveland	Ohio	44109-1998	—
Northeast Clinical Research	Allentown	Pennsylvania	18103	—
Southeast Renal Research Institute	Chattanooga	Tennessee	37404	—
Vanderbilt University Medical Center	Nashville	Tennessee	37232	—
Southwest Houston Research Ltd	Houston	Texas	77099	—
Purity Dialysis Centers / Nephrology Associates	Delafield	Wisconsin	53018	—
Gunderson Clinic Ltd.	La Crosse	Wisconsin	54601	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00888069, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 30, 2014 · Synced Nov 14, 2026