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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborator: |
Hoffmann-La Roche |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00275314 |
Purpose
This is a multi-center, open label, randomized, 3-way cross-over study. 21 subjects will be randomized to receive all three treatments in one of three treatment sequences.
Patients at risk of CMV disease (D+R-, D+R+, D-R+), who are being treated prophylactically with Valcyte® (commercially available tablets), after their first or second kidney transplant and who have adequate renal and hematological function will be eligible for the study. Screening may be at any time after transplantation provided that follow-up procedures can be completed during the scheduled time of prophylaxis. The first dose of study drug may be between 1 and 14 days after screening provided the transplant has stabilized, stable serum creatinine and steady-state kinetics of ganciclovir and calcineurin inhibitor therapy have been attained. Follow-up will take place 7- 14 days after last dose of study drug administration; therefore the duration of the study will be up to 5 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Transplant |
Drug: Valganciclovir |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | WP16302 A Bioequivalence Study Comparing Ganciclovir From the Valganciclovir Syrup Formulation and the Commercial Valganciclovir 450mg Tablet (Valcyte®) at a Dose of 900mg in Kidney Transplant Recipients, Sponsor Protocol Dated 8/11/2005 and Investigator Brochure Version August 2005 |
| Estimated Enrollment: | 5 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | April 2006 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 68 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient with adequate hematological and renal function defined as:
Patient able to participate, willing to give written, informed consent and comply with the study restrictions.
-
Exclusion Criteria:
Patients with any of the following will be excluded from the study:
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | David L Paterson, MD | University of Pittsburgh |
More Information
| ClinicalTrials.gov Identifier: | NCT00275314 History of Changes |
| Other Study ID Numbers: | IRB # 0512007 |
| Study First Received: | January 9, 2006 |
| Last Updated: | December 16, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
transplantation |
|
Ganciclovir Valganciclovir Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |