Renal Allograft RecipientsPhase 3NCT00470665
Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients
A Phase 3 study testing Rapamune in people with Renal Allograft Recipients, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Renal Allograft Recipients
- What is being tested?
- Rapamune
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Jul 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor.
- Age >= 13 years, weight >= 40 kg
- Women must have a negative pregnancy test at study entry
Who cannot join
- Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult)
- Active systemic infection, or localized major infection or known HIV
- Patients with residual kidney function >20 mL/min
About this study
Official title: An Open-Label, Concentration-Controlled, Randomized, 12-Month Study of Prograf + Rapamune + Corticosteroids Compared to Cyclosporine,USP (Modified) + Rapamune + Corticosteroids in High Risk Renal Allograft Recipients
The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.
- Conditions
- Renal Allograft Recipients
- Being tested
- Rapamune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamuneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2007 (estimated)
- Study startAug 2002
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Allograft RecipientsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 460 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470665
- Sponsor's protocol ID
- 0468H1-903
- Status last verified
- May 2007
- First submitted
- 7 May 2007
- Last updated
- 8 May 2007
- Results posted
- No
Publications
Oliveras L, Lopez-Vargas P, Melilli E, Codina S, Royuela A, Coloma Lopez A, Fava A, Manonelles A, Couceiro C, Lloberas N, Cruzado JM, Montero N. Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function. Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014855. doi: 10.1002/14651858.CD014855.pub2.
PubMed 40197799Gaber AO, Kahan BD, Van Buren C, Schulman SL, Scarola J, Neylan JF; Sirolimus High-Risk Study Group. Comparison of sirolimus plus tacrolimus versus sirolimus plus cyclosporine in high-risk renal allograft recipients: results from an open-label, randomized trial. Transplantation. 2008 Nov 15;86(9):1187-95. doi: 10.1097/TP.0b013e318187bab0.
PubMed 19005398
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Concentration-Controlled, Randomized, 12-Month Study of Prograf + Rapamune + Corticosteroids Compared to Cyclosporine,USP (Modified) + Rapamune + Corticosteroids in High Risk Renal Allograft Recipients
- ClinicalTrials.gov ID
- NCT00470665
- Acronym / sponsor ID
- 0468H1-903
- Conditions
- Renal Allograft Recipients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Jul 2004
- First posted
- 8 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor.
- Age >= 13 years, weight >= 40 kg
- Women must have a negative pregnancy test at study entry
Key exclusion criteria (3 listed)
- Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult)
- Active systemic infection, or localized major infection or known HIV
- Patients with residual kidney function >20 mL/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapamune | Drug | – |
Primary outcome
First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2007.
- Derived from this study: PubMed 40197799Oliveras L, Lopez-Vargas P, Melilli E, Codina S, Royuela A, Coloma Lopez A, Fava A, Manonelles A, Couceiro C, Lloberas N, Cruzado JM, Montero N. Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function. Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014855. doi: 10.1002/14651858.CD014855.pub2.
- Derived from this study: PubMed 19005398Gaber AO, Kahan BD, Van Buren C, Schulman SL, Scarola J, Neylan JF; Sirolimus High-Risk Study Group. Comparison of sirolimus plus tacrolimus versus sirolimus plus cyclosporine in high-risk renal allograft recipients: results from an open-label, randomized trial. Transplantation. 2008 Nov 15;86(9):1187-95. doi: 10.1097/TP.0b013e318187bab0.
Related trials for Renal Allograft Recipients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rapamune in people with Renal Allograft Recipients, run by Wyeth is now a wholly owned subsidiary of Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00470665, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2007.