Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects
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.
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
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
- Enrollment
- 28 participants
Conditions and interventions
Conditions
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 Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00888069 live on ClinicalTrials.gov.