Chronic Kidney FailurePhase 4NCT00044720
Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients
A Phase 4 study testing Rapamune in people with Chronic Kidney Failure and Graft vs Host Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The incidence of efficacy failure at 12 months between two regimens. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Chronic Kidney Failure, Graft vs Host Disease, Kidney Transplantation
- What is being tested?
- Rapamune
- How many people
- 484 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jul 2005
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 13 years or older, 40 kgs or more
- End-stage renal disease
- African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft
Who cannot join
- Evidence of active infection
- Evidence abnormal chest x-ray
- Patients with HIV.
About this study
Official title: An Open-label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor
The incidence of efficacy failure at 12 months between two regimens.
- Being tested
- Rapamune
- Keywords
- Kidney Transplant
- Medical subject headings
- Kidney Failure, Chronic, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamuneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2002 (estimated)
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, MD, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044720
- Sponsor's protocol ID
- 0468H1-101164
- Status last verified
- Aug 2009
- First submitted
- 4 Sep 2002
- Last updated
- 18 Aug 2009
- Results posted
- No