Transplant; Failure, KidneyPhase 4NCT01044303
Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA Study)
A Phase 4 study testing Myfortic Escalation in people with Transplant; Failure, Kidney, run by East Carolina University at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that increased dosages of mycophenolic acid in maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transplant; Failure, Kidney
- What is being tested?
- Myfortic Escalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Apr 2013
- Phase
- Phase 4
- 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
- Recipients of cadaveric, living related or living unrelated kidney transplant with positive DSA titer.
- Males and females, 18-75 years of age.
- Patients currently receiving MPA (500mg to 2500 mg of CellCept daily or 360 mg to 1800 mg of myfortic daily), cyclosporine or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 6 months.
- Females of childbearing potential must have a negative pregnancy test prior to enrollment. The test should be performed at baseline visit. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication.
- Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Who cannot join
- Multi-solid or cellular organ transplants (e.g. combined with pancreas, liver, islet, bone marrow), either concurrent or previous (with exception that a second kidney transplant is allowed).
- Evidence of graft rejection or treatment of acute rejection within 14 days prior to Baseline visit.
- Patients who have received any investigational drug within 4 weeks prior to study entry.
- Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<4,000/mm3), and/or hemoglobin <9.0 g/dL prior to enrollment.
- The presence of a severe GI disorder (such as Irritable Bowel Syndrome, Inflammatory Bowel Disease and known Peptic Ulcer Disease).
- Presence of clinically significant infection requiring continued therapy, chronic infection (e.g. HIV, Hep B and Hep C), malignancy (within last 5 years, except excised squamous or basal cell carcinoma of the skin), lymphoma or renal toxicity that would interfere with the appropriate conduct of the study.
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- Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin ≥ 3 times ULN) or severe diarrhea or active peptic ulcer disease that would interfere with the appropriate conduct of the study.
- Abnormal physical or laboratory findings of clinical significance within 2 weeks of inclusion which would interfere with the objectives of the study.
- Patients with symptoms of significant somatic or mental illness or evidence of drug and/or alcohol abuse.
- Patients receiving > 10 mg/day prednisone dose.
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures to MPA.
- Patients not making DSA antibodies.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (local); females of childbearing potential who are unwilling to use effective means of contraception and who are planning to become pregnant.
- Any other medical condition that, in the opinion of the site investigator based on recall or chart review would interfere with completing the study, including but not limited to visual problems or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27834
About this study
Official title: An Exploratory, Open-Label, Single Center Study to Assess the Efficacy and Dose Titration of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients
The purpose of this study is to demonstrate that increased dosages of mycophenolic acid in maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies.
Read the detailed description
The development of DSA post-transplant has been associated with chronic rejection and graft failure. EC-MPS is thought to be the key drug preventing both cellular and antibody mediated rejections. Several studies have shown that recipients receiving an optimal dose of EC-MPS have fewer antibody mediated rejections and may require a lower dose of calcineurin inhibitors and/or corticosteroids thus reducing side effects and extending graft survival.
- Conditions
- Transplant; Failure, Kidney
- Being tested
- Myfortic Escalation
- Keywords
- Kidney Transplantation, Mycophenolic Acid, Donor-Specific Antibodies, Kidney Rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myfortic EscalationDrug
Also called Enteric-coated mycophenolate sodium
Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of EC-MPS is achieved. Maximum dose will not exceed 2160 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Myfortic Escalation | Experimental | Participants EC-MPS dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations. Receives: Drug: Myfortic Escalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS)
Measured: 24 months
Secondary outcomes (1)
To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2013
- Study completionApr 2013
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 Transplant; Failure, KidneyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Paul Bolin, East Carolina University
- Investigators
- Paul Bolin, MD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044303
- Sponsor's protocol ID
- CERL080A-US78T
- Status last verified
- Oct 2014
- First submitted
- 6 Jan 2010
- Last updated
- 20 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open-Label, Single Center Study to Assess the Efficacy and Dose Titration of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT01044303
- Acronym / sponsor ID
- CERL080A-US78T
- Conditions
- Transplant; Failure, Kidney
- Keywords
- Kidney Transplantation, Mycophenolic Acid, Donor-Specific Antibodies, Kidney Rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jan 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Posted 20 Oct 2014
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 demonstrate that increased dosages of mycophenolic acid in maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies.
Detailed description
The development of DSA post-transplant has been associated with chronic rejection and graft failure. EC-MPS is thought to be the key drug preventing both cellular and antibody mediated rejections. Several studies have shown that recipients receiving an optimal dose of EC-MPS have fewer antibody mediated rejections and may require a lower dose of calcineurin inhibitors and/or corticosteroids thus reducing side effects and extending graft survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myfortic Escalation | Experimental | Drug: Myfortic EscalationParticipants EC-MPS dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recipients of cadaveric, living related or living unrelated kidney transplant with positive DSA titer.
- Males and females, 18-75 years of age.
- Patients currently receiving MPA (500mg to 2500 mg of CellCept daily or 360 mg to 1800 mg of myfortic daily), cyclosporine or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 6 months.
- Females of childbearing potential must have a negative pregnancy test prior to enrollment. The test should be performed at baseline visit. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication.
- Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Key exclusion criteria (14 listed)
- Multi-solid or cellular organ transplants (e.g. combined with pancreas, liver, islet, bone marrow), either concurrent or previous (with exception that a second kidney transplant is allowed).
- Evidence of graft rejection or treatment of acute rejection within 14 days prior to Baseline visit.
- Patients who have received any investigational drug within 4 weeks prior to study entry.
- Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<4,000/mm3), and/or hemoglobin <9.0 g/dL prior to enrollment.
- The presence of a severe GI disorder (such as Irritable Bowel Syndrome, Inflammatory Bowel Disease and known Peptic Ulcer Disease).
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 |
|---|---|---|
| Myfortic EscalationAlso: Enteric-coated mycophenolate sodiumDose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of EC-MPS is achieved. Maximum dose will not exceed 2160 mg daily. | Drug | Myfortic Escalation |
Primary outcome
Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS)
Time frame: 24 months
1 secondary outcome
To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased.
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- 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.
Paul Bolin, MD principal investigator
East Carolina University
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 Myfortic Escalation in people with Transplant; Failure, Kidney, run by East Carolina 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 5 inclusion and 14 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 20 Oct 2014. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2014). 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?
Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS) (time frame: 24 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 20 Oct 2014.