Kidney TransplantationPhase 4NCT00252655
Use of Sirolimus vs. Tacrolimus For African-American Renal Transplant Recipients
A Phase 4 study testing Rapamune and Prograf in people with Kidney Transplantation, run by Wayne State University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of Sirolimus (Rapamune) in improving the function of the transplant kidney, without any increase in the risk of acute rejection or adverse side effects, compared with Tacrolimus (Prograf). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Rapamune and Prograf
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jun 2009
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African-American living- or deceased-donor renal transplant at least 18 years of age with current and historical negative crossmatch who demonstrate urine output > 60 ml/hr and fall in serum creatinine > 20%/day during the first 48 hours posttransplant, without need for dialysis.
Who cannot join
- Unwillingness to participate in the study
- Current PRA > 20%
- Noncompliance with the protocol and follow-up visits
- Those who need to be on maintenance steroids due to underlying disease
- Known hypersensitivity to study drugs
- Pregnancy
- Pre-transplant leukopenia, thrombocytopenia, hypercholesterolemia, or hypertriglyceridemia despite optimal medical therapy
- HIV positive recipients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Detroit Medical Center, Harper University Hospital
Detroit, Michigan, 48201
About this study
Official title: Use of Sirolimus Vs. Tacrolimus As The Primary Agent In Immunosuppressive Regimen For African-American Renal Allograft Recipients With Immediate Graft Function: A Pilot Study
The purpose of this study is to evaluate the efficacy of Sirolimus (Rapamune) in improving the function of the transplant kidney, without any increase in the risk of acute rejection or adverse side effects, compared with Tacrolimus (Prograf).
We hypothesize that Sirolimus, as one component of a long-term steroid-free immunosuppressive regimen, will be effective in maintaining a low incidence of acute rejection and a short- and long-term graft survival comparable to Tacrolimus with better graft function in the high-risk African-American renal transplant population with immediate graft function.
Read the detailed description
It has been repeatedly demonstrated that African-American renal allograft recipients have worse graft outcomes when compared with Caucasians. This has been attributed to various immunologic and non-immunologic factors, including a greater rate of acute rejection, resistance to standard doses of calcineurin inhibitors (CNIs) and corticosteroids, different pharmacokinetic and pharmacodynamic profiles, and noncompliance. It has therefore been suggested that quadruple immunosuppression, including antilymphocyte antibodies for induction, should be used in this high-risk population to improve graft survival. CNIs are currently the mainstay of immunosuppressive regimens. Tacrolimus has been shown to be significantly more effective than Cyclosporine A in preventing acute rejection. As a result, Tacrolimus has become the CNI of choice in preventing acute rejection, and has produced similar graft survival rates at one year, with higher creatinine clearances. However, there is no report examining the efficacy of Sirolimus in improving renal function and its side effect profile when compared with Tacrolimus in renal allograft recipients, particularly in African-Americans with immediate graft function in a steroid-free environment.
- Conditions
- Kidney Transplantation
- Being tested
- Rapamune and Prograf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamune and PrografDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function at 1, 3, 6, and 12 months post transplant.
Secondary outcomes (1)
Incidence of acute rejection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startJan 2004
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Investigators
- Scott A. Gruber, MD, PhD, Principal investigator, Harper University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252655
- Sponsor's protocol ID
- 122102M1F
- Status last verified
- Apr 2007
- First submitted
- 9 Nov 2005
- Last updated
- 19 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sirolimus Vs. Tacrolimus As The Primary Agent In Immunosuppressive Regimen For African-American Renal Allograft Recipients With Immediate Graft Function: A Pilot Study
- ClinicalTrials.gov ID
- NCT00252655
- Acronym / sponsor ID
- 122102M1F
- Conditions
- Kidney Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Jun 2009
- First posted
- 11 Nov 2005 (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 evaluate the efficacy of Sirolimus (Rapamune) in improving the function of the transplant kidney, without any increase in the risk of acute rejection or adverse side effects, compared with Tacrolimus (Prograf).
We hypothesize that Sirolimus, as one component of a long-term steroid-free immunosuppressive regimen, will be effective in maintaining a low incidence of acute rejection and a short- and long-term graft survival comparable to Tacrolimus with better graft function in the high-risk African-American renal transplant population with immediate graft function.
Detailed description
It has been repeatedly demonstrated that African-American renal allograft recipients have worse graft outcomes when compared with Caucasians. This has been attributed to various immunologic and non-immunologic factors, including a greater rate of acute rejection, resistance to standard doses of calcineurin inhibitors (CNIs) and corticosteroids, different pharmacokinetic and pharmacodynamic profiles, and noncompliance. It has therefore been suggested that quadruple immunosuppression, including antilymphocyte antibodies for induction, should be used in this high-risk population to improve graft survival. CNIs are currently the mainstay of immunosuppressive regimens. Tacrolimus has been shown to be significantly more effective than Cyclosporine A in preventing acute rejection. As a result, Tacrolimus has become the CNI of choice in preventing acute rejection, and has produced similar graft survival rates at one year, with higher creatinine clearances. However, there is no report examining the efficacy of Sirolimus in improving renal function and its side effect profile when compared with Tacrolimus in renal allograft recipients, particularly in African-Americans with immediate graft function in a steroid-free environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- African-American living- or deceased-donor renal transplant at least 18 years of age with current and historical negative crossmatch who demonstrate urine output > 60 ml/hr and fall in serum creatinine > 20%/day during the first 48 hours posttransplant, without need for dialysis.
Key exclusion criteria (8 listed)
- Unwillingness to participate in the study
- Current PRA > 20%
- Noncompliance with the protocol and follow-up visits
- Those who need to be on maintenance steroids due to underlying disease
- Known hypersensitivity to study drugs
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 and Prograf | Drug | – |
Primary outcome
Renal function at 1, 3, 6, and 12 months post transplant.
1 secondary outcome
Incidence of acute rejection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
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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.
Scott A. Gruber, MD, PhD principal investigator
Harper University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rapamune and Prograf in people with Kidney Transplantation, run by Wayne State University at 1 site in United States.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Renal function at 1, 3, 6, and 12 months post transplant.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2007.