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Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA Study) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA Study)

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

NCT01044303•East Carolina University

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 (\<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.
•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.
+4 more criteria

Locations (1)

East Carolina University

Greenville, North Carolina, United States

Key Dates

Start Date

January 1, 2010

Primary Completion Date

April 1, 2013

Completion Date

April 1, 2013

Last Updated

October 20, 2014

Enrollment

ACTUAL participants

Conditions

Transplant; Failure, Kidney

Interventions

Myfortic Escalation

DRUG

Quality of Life in Pre and Post Renal Transplant in Hispanic and Non-Hispanic Recipients

NCT00856895

Transplant; Failure, Kidney

View study

COMPLETED

Compliance/Adherence After Kidney Transplant, With or With Out Med-O-Wheel™.

NCT01709097

Medication AdherenceCompliance+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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