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Immunosuppressant

Myfortic for Type 1 Diabetes Islet Transplant Recipients

N/A
Recruiting
Led By Rodolfo Alejandro, MD
Research Sponsored by Rodolfo Alejandro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of at least one islet transplant
Male and female patients age 18-70 years of age
Must not have
History on non-adherence to prescribed regimens including immunosuppression
Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people who have had a transplant of islet cells (which help produce insulin in the pancreas) that has failed, and now have very low levels of a protein called c-peptide.

Who is the study for?
This trial is for adults aged 18-70 with Type 1 Diabetes who've had at least one islet transplant but now have complete graft loss. They must be on or able to stop immunosuppressants, mentally stable, and not pregnant or breastfeeding. Exclusions include a history of severe diseases like cancer (except certain skin cancers), heart disease, untreated high cholesterol, obesity, hypertension, liver issues, and active infections.
What is being tested?
The study tests Myfortic in individuals who have experienced complete loss of their transplanted islet cells after treatment for Type 1 Diabetes. It's an open-label trial where all participants receive the drug to see if it can prevent new immune sensitivities from developing post-graft rejection.
What are the potential side effects?
While specific side effects are not listed here, Myfortic as an immunosuppressive medication may generally cause stomach problems like diarrhea or nausea; blood cell count changes leading to increased infection risk; potential liver issues; and possibly other organ-related inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least one islet cell transplant.
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I am between 18 and 70 years old.
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I am not taking any immunosuppressive medications or have stopped them as required for islet transplantation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not always followed my prescribed medical treatments.
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I have untreated severe high cholesterol, obesity, or hard-to-control high blood pressure.
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I do not have severe heart disease, recent heart attacks, or very poor heart function.
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I have had cancer before, but it was completely removed except for skin cancer.
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I am currently pregnant or breastfeeding.
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I have an active stomach or intestinal ulcer.
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I have no active infections like hepatitis B, C, HIV, or TB.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
allosensitization after complete islet graft loss

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Myfortic treatmentExperimental Treatment1 Intervention
Treatment with Myfortic
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Myfortic
2010
Completed Phase 4
~1180

Find a Location

Who is running the clinical trial?

Rodolfo AlejandroLead Sponsor
9 Previous Clinical Trials
196 Total Patients Enrolled
Rodolfo Alejandro, MDPrincipal Investigator - University of Miami
University Of Puerto Rico School Of Medicine (Medical School)
University Hospital (Residency)
7 Previous Clinical Trials
135 Total Patients Enrolled

Media Library

Myfortic (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT01999361 — N/A
Diabetes Research Study Groups: Myfortic treatment
Diabetes Clinical Trial 2023: Myfortic Highlights & Side Effects. Trial Name: NCT01999361 — N/A
Myfortic (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01999361 — N/A
~2 spots leftby Jan 2027
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