Kidney TransplantationPhase 2NCT01053221
Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation
A Phase 2 study testing Mycophenolic Acid in people with Kidney Transplantation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This randomized trial will enroll adult recipients of HLA-identical living kidney transplants who are at least 1 year post-transplant. All subjects will be taking Prograf (tacrolimus) or cyclosporine and mycophenolic acid (CellCept or Myfortic) and then be randomized (1:2) to either continue calcineurin inhibitors or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Mycophenolic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Aug 2012
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18-75 years of age.
- Subjects who are recipients of HLA-identical living donor renal allografts from a sibling and are at least 1 year post transplant, their donors and mothers.
- Subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
Who cannot join
- GFR <40ml/min;
- diagnosis of SLE,
- Subjects with proteinuria (defined as a protein:creatinine ratio of >1 or an amount less than this deemed significant on an individual subject basis by the principal investigator),,
- multi-organ transplant;
- known hypersensitivity to, Prograf, Neoral, CellCept or Myfortic;
- history of documented post transplant non-compliance with medications, transplant clinic or laboratory follow-up;
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- therapy with an investigational immunosuppressive drug within 6 weeks of study entry;
- history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study;
- patients on less than 500 mg PO BID of CellCept or 360 mg PO BID of Myfortic at the time of potential randomization,
- history of humoral rejection post transplant,
- maintenance or for cause treatment with steroids (prednisone) within 3 months of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized trial will enroll adult recipients of HLA-identical living kidney transplants who are at least 1 year post-transplant. All subjects will be taking Prograf (tacrolimus) or cyclosporine and mycophenolic acid (CellCept or Myfortic) and then be randomized (1:2) to either continue calcineurin inhibitors or to taper off of calcineurin inhibitors. The hypothesis is that mycophenolic acid monotherapy permits long-term rejection-free renal allograft function in the absence of long-term calcineurin inhibitors in this fully matched renal transplant cohort.
Read the detailed description
The objective of the study is to safely move HLA-identical renal transplant recipients from 2 immunosuppressive drugs (calcineurin inhibitor and mycophenolic acid) to mycophenolic acid monotherapy. Safety will be assessed by monitoring renal function in subjects in the withdrawal group compared to those who remain on the standard 2-drug immunosuppression protocol. Results of immunological monitors such as DTH regulation in response to donor minor antigens and development of anti-donor antibodies will be correlated with successful withdrawal.
- Conditions
- Kidney Transplantation
- Being tested
- Mycophenolic Acid, Standard of Care: CNI and MPA
- Keywords
- mycophenolate, living donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolic AcidDrug
Also called cellcept, myfortic
Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months
Standard of Care: CNI and MPADrug
Tacrolimus or cyclosporine: dosed according to trough levels per standard of care Mycophenolate mofetil 750mg po bid or mycophenolate sodium 540mg po bid x 36 months
| Study group | Role | What they receive |
|---|---|---|
| MPA monotherapy | Experimental | Subjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy Receives: Drug: Mycophenolic Acid |
| Control: MPA and CNI | Active comparator | Subjects will continue with their current immunosuppressive regimen of MPA (mycophenolate mofetil or mycophenolate sodium) and calcineurin inhibitor (cyclosporine or tacrolimus) Receives: Drug: Standard of Care: CNI and MPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Kidney Allograft Rejection and Graft Loss
Measured: 36 months
Secondary outcomes (4)
Renal Function Measured by Serum Creatinine and eGFR
Measured: 36 months
Number of Incidences of Infection and Malignancy
Number of incidences of infection and malignancy will be reported.
Measured: 36 months
Patient Survival
patient survival
Measured: 36 months
Trans-vivo Delayed Type Hypersensitivity (DTH) Assay
Delayed type hypersensitivity (DTH) reactivity status to donor and minor antigens will be detected using trans-vivo DTH assay. This information will help determine if T-regulatory cells are present, and whether such cells predict outcome of Calcineurin inhibitor withdrawal.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startMar 2006
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Funding loss
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 Kidney 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Burlingham, PhD, Principal investigator, University of Wisconsin, MadisonHans Sollinger, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053221
- Sponsor's protocol ID
- H-2005-0357
- Other IDs
- 2012-0343
- Status last verified
- Jun 2019
- First submitted
- 19 Jan 2010
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation
- ClinicalTrials.gov ID
- NCT01053221
- Acronym / sponsor ID
- H-2005-0357
- Conditions
- Kidney Transplantation
- Keywords
- mycophenolate, living donor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding loss
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized trial will enroll adult recipients of HLA-identical living kidney transplants who are at least 1 year post-transplant. All subjects will be taking Prograf (tacrolimus) or cyclosporine and mycophenolic acid (CellCept or Myfortic) and then be randomized (1:2) to either continue calcineurin inhibitors or to taper off of calcineurin inhibitors. The hypothesis is that mycophenolic acid monotherapy permits long-term rejection-free renal allograft function in the absence of long-term calcineurin inhibitors in this fully matched renal transplant cohort.
Detailed description
The objective of the study is to safely move HLA-identical renal transplant recipients from 2 immunosuppressive drugs (calcineurin inhibitor and mycophenolic acid) to mycophenolic acid monotherapy. Safety will be assessed by monitoring renal function in subjects in the withdrawal group compared to those who remain on the standard 2-drug immunosuppression protocol. Results of immunological monitors such as DTH regulation in response to donor minor antigens and development of anti-donor antibodies will be correlated with successful withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPA monotherapy | Experimental | Drug: Mycophenolic AcidSubjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy |
| Control: MPA and CNI | Active comparator | Drug: Standard of Care: CNI and MPASubjects will continue with their current immunosuppressive regimen of MPA (mycophenolate mofetil or mycophenolate sodium) and calcineurin inhibitor (cyclosporine or tacrolimus) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects 18-75 years of age.
- Subjects who are recipients of HLA-identical living donor renal allografts from a sibling and are at least 1 year post transplant, their donors and mothers.
- Subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
Key exclusion criteria (11 listed)
- GFR <40ml/min;
- diagnosis of SLE,
- Subjects with proteinuria (defined as a protein:creatinine ratio of >1 or an amount less than this deemed significant on an individual subject basis by the principal investigator),,
- multi-organ transplant;
- known hypersensitivity to, Prograf, Neoral, CellCept or Myfortic;
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 |
|---|---|---|
| Mycophenolic AcidAlso: cellcept, myforticMycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months | Drug | MPA monotherapy |
| Standard of Care: CNI and MPATacrolimus or cyclosporine: dosed according to trough levels per standard of care Mycophenolate mofetil 750mg po bid or mycophenolate sodium 540mg po bid x 36 months | Drug | Control: MPA and CNI |
Primary outcome
Incidence of Kidney Allograft Rejection and Graft Loss
Time frame: 36 months
4 secondary outcomes
Renal Function Measured by Serum Creatinine and eGFR
Time frame: 36 months
Number of Incidences of Infection and Malignancy
Time frame: 36 months
Patient Survival
Time frame: 36 months
Trans-vivo Delayed Type Hypersensitivity (DTH) Assay
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- 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.
William Burlingham, PhD principal investigator
University of Wisconsin, Madison
Hans Sollinger, MD, PhD 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 Phase 2 study testing Mycophenolic Acid in people with Kidney 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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 Jul 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jul 2019). 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?
Incidence of Kidney Allograft Rejection and Graft Loss (time frame: 36 months). 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 5 Jul 2019.