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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

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Myfortic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Myfortic® Monotherapy to Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
Study Start Date : January 2009
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: Myfortic treatment
Treatment with Myfortic
Drug: Myfortic
treatment with myfortic
Other Name: mycophenolic acid




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999361


Locations
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United States, Florida
Diabetes Research Institute Recruiting
Miami, Florida, United States, 33136
Contact: Rodolfo Alejandro, MD    305-243-5321    islet@med.miami.edu   
Principal Investigator: Rodolfo Alejandro, MD         
Sponsors and Collaborators
Rodolfo Alejandro
Investigators
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Principal Investigator: Rodolfo Alejandro, MD University of Miami

Additional Information:
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Responsible Party: Rodolfo Alejandro, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT01999361     History of Changes
Other Study ID Numbers: 20071058
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Mycophenolic Acid
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action