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Completed Phase 1 Interventional

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

Public ClinicalTrials.gov record NCT00888069. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 6:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 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

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
Apr 30, 2009
Primary completion
Oct 31, 2009
Completion
Nov 30, 2009
Last update posted
Sep 29, 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 29, 2014 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00888069 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →