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DiabetesNCT01387659

Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations

A study testing Gastric emptying test in people with Diabetes and Immunosuppression, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is designed to evaluate the tolerability of Myfortic®/Simulect® combination in diabetic patients in a steroid free regimen. Due to the diverse ethnicity of our transplant recipient population, the study will determine any different responses, including autoimmunity, between Hispanic, and Caucasian, patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes, Immunosuppression
What is being tested?
Gastric emptying test
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Mar 2011to Oct 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (age 18 to 65 years of age), male or female Hispanic or Caucasian.
  • Primary kidney or kidney transplant patients (cadaveric, living related, or living unrelated)
  • Written inform consent obtained. The patients are willing to participate in the study at UTMB.
  • Female with negative pregnancy test.
  • PRA < 20 %.
  • En-blocks and two kidneys (tx'd at the same time) will be allowed.
  • Cold Ischemia time ≤ 30 hrs
  • Hep C patients will be allowed to enroll in this study

Who cannot join

  • Multi-organ transplants
  • Transplant from non-heart beating donor (NHBD) or dual transplants
  • A-B-O incompatible or positive cross match
  • Conditions which significantly alter the absorption, distribution, and metabolism (except for diarrhea) of medications.
  • Women of childbearing potential not using contraception method(s) as well as women who are breastfeeding
  • Inability to tolerate oral medications
Show all 12Show fewer
  • Inability to sign a written consent form or to cooperate with investigators
  • Use of an investigational medication in the past 30 days.
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
  • HIV positive patients
  • History of psychosocial instability
  • Mental incompetence

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Medical Branch

    Galveston, Texas, 77555

Other trials in United States

About this study

Official title: Study to Evaluate Tolerability of Myfortic With Simulect Induction and Tacrolimus Without Steroids in Three Patient Populations; 1: Kidney/Pancreas Transplants,2: Diabetic Kidney Transplants, and 3: Non-diabetic Kidney Transplants

This study is designed to evaluate the tolerability of Myfortic®/Simulect® combination in diabetic patients in a steroid free regimen. Due to the diverse ethnicity of our transplant recipient population, the study will determine any different responses, including autoimmunity, between Hispanic, and Caucasian, patients.

Read the detailed description

Myfortic® is an enteric-coated formulation of the sodium salt derivative of mycophenolic acid (MPA) that is administered to control kidney graft rejection. Myfortic® was developed to improve MPA-related upper gastrointestinal (GI) side effects by delaying the release of MPA until it reaches the large surface of the small bowel. Approximately half of all the kidney transplant recipients in the United States have diabetes mellitus. A recent analysis of approximately 30,000 kidney transplant recipients included in the U.S. Renal Data System showed that 42% of patients had pre-transplant diabetes (1). Moreover, 15% to 20% of patients develop diabetes after transplantation, a condition that is commonly known as post-diabetes mellitus (1-3). It was previously shown that the rate and extent of MPA absorption is minimally affected by diabetes (4). Limited data is available in the current literature on Myfortic® and Simulect® based therapy in diabetic patients.

Being tested
Gastric emptying test
Keywords
Myfortic, Simulect, Steroids, Diabetes, Transplant, Gastric emptying, Gastric motility
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gastric emptying testProcedure or surgery

    Also called Gastric motility

    Gastric emptying tests will be performed at baseline, 6 months and 12 months

Study groups in NCT01387659
Study groupRoleWhat they receive
Transplant recipientsExperimentalAll subjects receive identical drug treatment
Receives: Procedure: Gastric emptying test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids

    Assure that immunosuppression protects graft function by decreased incidence of rejection and side effects

    Measured: 24 months

Secondary outcomes (3)

  1. GI complications

    Gastric emptying test

    Measured: 24 months

  2. Graft function

    Renal function assessed by serum creatinine and calculating creatinine clearance.

    Pancreas function assessed by glucose control, exogenous insulin requirement, HgbA1C

    Measured: 24 months

  3. Biopsy proven rejection

    Renal graft core biopsy will be performed on all suspected rejection.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionOct 2012
  4. Study completionOct 2012

Why it stopped: Study terminated due to slow enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01387659
Sponsor's protocol ID
10-244
Status last verified
Sep 2013
First submitted
8 Jun 2011
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Gastric emptying test in people with Diabetes and Immunosuppression, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study terminated due to slow enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01387659.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.

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