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

NCT01044303 | Completed Phase 4 Results

• 1 other identifier: CERL080A-US78T
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transplant; Failure, Kidney

Keywords

Kidney Transplantation; Mycophenolic Acid; Donor-Specific Antibodies; Kidney Rejection

Outcome Measures

Primary Outcomes (1)

• Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS)

  24 months

Secondary Outcomes (1)

• To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased.

  24 months

Study Arms (1)

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.

Drug: Myfortic Escalation

Interventions

Myfortic Escalation DRUG

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.

Also known as: Enteric-coated mycophenolate sodium

Myfortic Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• East Carolina University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Limitations and Caveats

Lost to follow-up was a limitation in this study.

Results Point of Contact

• Title: Dr. Paul Bolin
• Organization: East Carolina University

bolinp@ecu.edu

252-744-3773

Study Officials

• Paul Bolin, MD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Internal Medicine

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 7, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 20, 2014
• Results First Posted: October 20, 2014

Record last verified: 2014-10

Locations

US (1)