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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I am mentally stable and can follow the study's procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

allosensitization after complete islet graft loss

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rodolfo AlejandroLead Sponsor

9 Previous Clinical Trials

244 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

Type 1 Diabetes Research Study Groups: Myfortic treatment

Type 1 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical trial still have available vacancies?

"The information available on clinicaltrials.gov reveals that the recruitment process is ongoing for this particular study, which was initially posted in January 2009 and last modified in March 2022."

Answered by AI

How many individuals are engaging in the research?

"Affirmative. Clinicaltrials.gov confirms that this clinical study, which was posted on January 1st 2009, is actively recruiting participants. The trial requires 18 volunteers to be sourced from a single medical centre."

Answered by AI

Do I fulfill the requirements to take part in this research?

"This medical study requires 18 participants with diabetes and/or autoimmune diseases, aged between eighteen and seventy. Additionally, the candidates must be mentally sound and compliant to abide by this trial's protocols; have a history of at least one islet transplantation procedure; not currently prescribed immunosuppressive medications (or if so, need to discontinue them as per protocol); male or female patients."

Answered by AI

Does this trial accept applicants who are younger than forty years old?

"The eligiblity requirements for this trial state that the minimum age of entry is 18 years old, with a maximum enrollment age being 70."

Answered by AI

Are there any other investigations involving the use of Myfortic?

"Currently, 25 trials concerning Myfortic are in progress. 5 of these experiments have reached Phase 3 while the bulk is located in Saint Louis, Missouri. In total, 265 different sites are running studies on this drug."

Answered by AI

Recent research and studies

TransplantationJournal

Long-term Persistence of Allosensitization After Islet Allograft Failure

Rios, Paola, David Baidal, Joana Lemos, Stephanie S. Camhi, Marco Infante, Nathalia Padilla, Ana M. Alvarez Gil, et al.. 2021. “Long-term Persistence of Allosensitization After Islet Allograft Failure”. Transplantation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/tp.0000000000003635.

clinicaltrials.govStudy

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

Rodolfo Alejandro 2009. "Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01999361.

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