Renal TransplantationNCT00214279
MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal
A study testing Corticosteroid withdrawal in people with Renal Transplantation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and MMF), while carefully monitoring their graft function. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Corticosteroid withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Nov 2007
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who have received a kidney transplant during the "MMF era"
- Patients who have stable graft function indicated by a serum creatinine of < 1.8 mg/dl, or a calculated creatinine clearance of > 50 ml/minute
Who cannot join
- Patients who have had > 1 rejection episode,
- Patients who have had a rejection episode within the past year;
- Patients who are steroid dependent due to pre-existing disease (for example, RA or SLE
Trial locations and contacts
1 site in 1 country.
About this study
Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and MMF), while carefully monitoring their graft function. 25 subjects would serve as control patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and MMF). Immunologic status will be determined before and after IS withdrawal using a delayed-type hypersensitivity (DTH) transfer test previously described in the original submission. Both the steroid withdrawal subjects and the control subjects will undergo the DTH testing throughout the 3 years of study participation.
- Conditions
- Renal Transplantation
- Being tested
- Corticosteroid withdrawal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid withdrawalDrug
prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Remain on 3-drug standard of care immunosuppression including prednisone |
| 2 | Experimental | Corticosteroid withdrawal / prednisone taper over 14 weeks Receives: Drug: Corticosteroid withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Allograft rejection
Measured: 3 years
Secondary outcomes (3)
Renal function as determined by serum creatinine
Measured: measure after 36 months
Allograft Survival
Measured: 3 years
Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH)
Research assay done to determine correlation between the status of donor specific regulation (DSR) and rates of rejection in both arms of the study.
Measured: Day 0 (pre-transplant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Sollinger, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214279
- Sponsor's protocol ID
- 2002-040
- Other IDs
- CEL340
- Status last verified
- Jun 2012
- First submitted
- 14 Sep 2005
- Last updated
- 26 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal
- ClinicalTrials.gov ID
- NCT00214279
- Acronym / sponsor ID
- 2002-040
- Conditions
- Renal Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- May 2002
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 21 Sep 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.
Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and MMF), while carefully monitoring their graft function. 25 subjects would serve as control patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and MMF). Immunologic status will be determined before and after IS withdrawal using a delayed-type hypersensitivity (DTH) transfer test previously described in the original submission. Both the steroid withdrawal subjects and the control subjects will undergo the DTH testing throughout the 3 years of study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Remain on 3-drug standard of care immunosuppression including prednisone |
| 2 | Experimental | Drug: Corticosteroid withdrawalCorticosteroid withdrawal / prednisone taper over 14 weeks |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who have received a kidney transplant during the "MMF era"
- Patients who have stable graft function indicated by a serum creatinine of < 1.8 mg/dl, or a calculated creatinine clearance of > 50 ml/minute
Key exclusion criteria (3 listed)
- Patients who have had > 1 rejection episode,
- Patients who have had a rejection episode within the past year;
- Patients who are steroid dependent due to pre-existing disease (for example, RA or SLE
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 |
|---|---|---|
| Corticosteroid withdrawalprednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus | Drug | 2 |
Primary outcome
Incidence of Allograft rejection
Time frame: 3 years
3 secondary outcomes
Renal function as determined by serum creatinine
Time frame: measure after 36 months
Allograft Survival
Time frame: 3 years
Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH)
Time frame: Day 0 (pre-transplant)
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 26 Jun 2012.
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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.
Hans Sollinger, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid withdrawal in people with Renal Transplantation, run by University of Wisconsin, Madison 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 2 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 26 Jun 2012. 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.
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?
Incidence of Allograft rejection (time frame: 3 years). 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 26 Jun 2012.