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Trial record 34 of 1167 for:    MYCOPHENOLIC ACID

Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

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ClinicalTrials.gov Identifier: NCT01999361
Recruitment Status : Recruiting
First Posted : December 3, 2013
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Rodolfo Alejandro, University of Miami

Tracking Information
First Submitted Date  ICMJE November 25, 2013
First Posted Date  ICMJE December 3, 2013
Last Update Posted Date July 16, 2019
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
allosensitization after complete islet graft loss [ Time Frame: 3 years ]
Allosensitization after complete islet graft loss after completion of two years of Myfortic® maintenance monotherapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01999361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
Official Title  ICMJE Myfortic® Monotherapy to Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
Brief Summary This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.
Detailed Description After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus and tacrolimus) will be discontinued and they will be placed on Myfortic® monotherapy for 2 years thereafter. After completion of two years of Myfortic® maintenance monotherapy, it will be weaned and subjects will be monitored over the subsequent twelve months, for the appearance of sensitization using panel reactive antibody (PRA) levels.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE Drug: Myfortic
treatment with myfortic
Other Name: mycophenolic acid
Study Arms  ICMJE Experimental: Myfortic treatment
Treatment with Myfortic
Intervention: Drug: Myfortic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2013)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female patients age 18-70 years of age.
  2. Ability to provide written informed consent.
  3. Mentally stable and able to comply with the procedures of the study protocol.
  4. Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
  5. History of at least one islet transplant.
  6. Stimulated C-peptide <0.3 ng/ml.

Exclusion Criteria:

  1. Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
  2. For female participants: Positive pregnancy test or presently breast-feeding.
  3. History of active infection including hepatitis B, hepatitis C, HIV, or TB.
  4. Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.
  5. Known active alcohol or substance abuse.
  6. Severe co-existing history of cardiac disease, characterized by a history of any one of these conditions: recent myocardial infarction (within past 6 months), evidence of ischemia on functional cardiac exam within the last year, or left ventricular ejection fraction <30%.
  7. History of persistent elevation of liver function tests. SGOT (AST), SGPT (ALT), alkaline phosphatase or total bilirubin, with values >1.5 times normal upper limits will exclude a patient.
  8. Evidence of inter-current infection.
  9. Active peptic ulcer disease
  10. History on non-adherence to prescribed regimens including immunosuppression.
  11. PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01999361
Other Study ID Numbers  ICMJE 20071058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Rodolfo Alejandro, University of Miami
Study Sponsor  ICMJE Rodolfo Alejandro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodolfo Alejandro, MD University of Miami
PRS Account University of Miami
Verification Date July 2019

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