End Stage Renal DiseasePhase 2/3NCT00189202
Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
A Phase 2/3 study testing Sirolimus in people with End Stage Renal Disease and Kidney Transplantation, run by University of Michigan at 1 site in United States.
Trial summary
African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Kidney Transplantation
- What is being tested?
- Sirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to 1 Jul 2008
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 recipient race
- Solitary cadaveric or living donor renal transplantation
- Age ≥18years at the time of transplantation
- Negative pregnancy serum test in females with childbearing potential
Who cannot join
- Age < 18 years at the time of transplantation
- Multi-organ transplant recipient
- Currently taking steroids
- White Blood Cell Count < 3,000
- Platelet count < 100,000
- Triglycerides >400mg/dL
Show all 9Show fewer
- Cholesterol > 350 mg/dL
- Unwillingness to comply with study procedures
- Allergic reaction to sirolimus Allergy to polyclonal antilymphocyte drugs (Thymoglobulin)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health Center
Ann Arbor, Michigan, 48109
About this study
Official title: Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients
African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes.
This study will evaluate:
- Whether a sirolimus based steroid avoidance regimen in African Americans may decrease the risks of drug-related toxicities,
- Decreased rates of metabolic complications such as post-transplant diabetes,
- The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.
Read the detailed description
This is an open labeled prospective trial with race matched historical controls. The treatment group (experimental arm) will be African American de novo solitary renal transplant recipients. The control arm will consist of race matched solitary renal transplant recipients who received a Cyclosporine (CsA) -based immunosuppressive regimen. The subjects will be matched for organ source (living donor vs. cadaveric). The experimental treatment arm will have an immunosuppression regimen consisting of Sirolimus, Reduced dose cyclosporine, Thymoglobulin, and only 3 doses of steroids.
- Conditions
- End Stage Renal Disease, Kidney Transplantation
- Being tested
- Sirolimus
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamune
Thymoglobulin induction, sirolimus and no maintenance corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus, steroid avoidance arm | Experimental | Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Receives: Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative One-year Acute Rejection Rates
To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant
Measured: 12 months
One-year Graft Survival
To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival
Measured: 12 months
One-year Patient Survival
To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival
Measured: 12 months
Secondary outcomes (3)
Incidence of Post Transplant Diabetes
To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus
Measured: 12 months
Drug-treated Dyslipidemic Syndrome
To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome
Measured: 12 months
Blood Pressure Control
To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startAug 2004
- Primary completion1 Jul 2008
- Study completion1 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, Akinlolu Ojo, University of Michigan
- Investigators
- Akinlolu Ojo, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189202
- Sponsor's protocol ID
- Steroid Avoidance in A.A.
- Status last verified
- Feb 2018
- First submitted
- 13 Sep 2005
- Last updated
- 27 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT00189202
- Acronym / sponsor ID
- Steroid Avoidance in A.A.
- Conditions
- End Stage Renal Disease, Kidney Transplantation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Aug 2004
- Primary completion
- 1 Jul 2008 (actual)
- Study completion
- 1 Jul 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 5 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes.
This study will evaluate:
- Whether a sirolimus based steroid avoidance regimen in African Americans may decrease the risks of drug-related toxicities,
- Decreased rates of metabolic complications such as post-transplant diabetes,
- The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.
Detailed description
This is an open labeled prospective trial with race matched historical controls. The treatment group (experimental arm) will be African American de novo solitary renal transplant recipients. The control arm will consist of race matched solitary renal transplant recipients who received a Cyclosporine (CsA) -based immunosuppressive regimen. The subjects will be matched for organ source (living donor vs. cadaveric). The experimental treatment arm will have an immunosuppression regimen consisting of Sirolimus, Reduced dose cyclosporine, Thymoglobulin, and only 3 doses of steroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sirolimus, steroid avoidance arm | Experimental | Drug: SirolimusThymoglobulin induction, sirolimus and no maintenance corticosteroid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- African American recipient race
- Solitary cadaveric or living donor renal transplantation
- Age ≥18years at the time of transplantation
- Negative pregnancy serum test in females with childbearing potential
Key exclusion criteria (9 listed)
- Age < 18 years at the time of transplantation
- Multi-organ transplant recipient
- Currently taking steroids
- White Blood Cell Count < 3,000
- Platelet count < 100,000
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 |
|---|---|---|
| SirolimusAlso: RapamuneThymoglobulin induction, sirolimus and no maintenance corticosteroid | Drug | Sirolimus, steroid avoidance arm |
Primary outcome
Cumulative One-year Acute Rejection Rates
Time frame: 12 months
To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant
One-year Graft Survival
Time frame: 12 months
To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival
One-year Patient Survival
Time frame: 12 months
To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival
3 secondary outcomes
Incidence of Post Transplant Diabetes
Time frame: 12 months
Drug-treated Dyslipidemic Syndrome
Time frame: 12 months
Blood Pressure Control
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Akinlolu Ojo, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sirolimus in people with End Stage Renal Disease and Kidney Transplantation, run by University of Michigan 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 4 inclusion and 9 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 27 Mar 2018. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 5 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cumulative One-year Acute Rejection Rates (time frame: 12 months). The study lists 3 primary outcomes in all. 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 27 Mar 2018.