Phase 4
Completed N=32
Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA Study)
Transplant; Failure, Kidney
Source: ClinicalTrials.gov NCT01044303 ↗
Enrolled (actual)
32
Serious AEs
16.7%
Results posted
Oct 2014
Primary outcomePrimary: Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS) — 43.1 percent of MFI change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS) |
43.1 | — |
| SECONDARY To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased. |
2; 2; 29 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion criteria
- 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 ( 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.
Data sourced from ClinicalTrials.gov (NCT01044303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.