Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Paul Bolin, East Carolina University
ClinicalTrials.gov Identifier:
NCT01044303
First received: January 6, 2010
Last updated: October 16, 2014
Last verified: October 2014

January 6, 2010
October 16, 2014
January 2010
April 2013   (final data collection date for 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 ] [ Designated as safety issue: No ]
To evaluate reduction in donor-specific antibody strength as optimal mycophenolic acid dose is achieved. [ Time Frame: monthly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01044303 on ClinicalTrials.gov Archive Site
To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
To assess the rate of rejection, infection and renal function as mycophenolic acid dose is increased. [ Time Frame: Baseline, every 3 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Transplant; Failure, Kidney
Drug: Myfortic Escalation
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.
Other Name: Enteric-coated mycophenolate sodium
Experimental: Myfortic Escalation
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.
Intervention: Drug: Myfortic Escalation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
  • 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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01044303
CERL080A-US78T
No
Paul Bolin, East Carolina University
East Carolina University
Novartis Pharmaceuticals
Principal Investigator: Paul Bolin, MD East Carolina University
East Carolina University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP