Pancreatic Islet Cell Transplantation After Kidney Transplantation - A Novel Approach to Immunosupression

Withdrawn before enrolling · Phase 1

Conditions studied: Islet Cell Transplantation, Type 1 Diabetes

In brief

The purpose of this study is to further test islet cell transplant in patients who have had a kidney transplant. This study will also evaluate the safety and effectiveness of the anti-rejection medications used to prevent rejection after your islet cell transplant.

Key facts

Study ID

NCT03047200

Run by

Baylor Research Institute

People needed

0

Starts

2008-07-01

Expected to finish

2017-01-01

Last updated by the study team

2017-02-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 24 months.
• Type 1 diabetes mellitus of more than 5 years duration
• Age between 18 and 65
• Unstable diabetes mellitus control despite expert management by a diabetology care team for at least 6 months prior to consideration for transplantation as defined by the following:
• During the past six months (or during the period of intensive diabetes care): Any episodes of hypoglycemic unawareness, as defined by the inability to recognize glucose levels below 50 mg/dL; or episodes of loss of cognitive function; or frequent episodes of symptomatic hypoglycemia; or admission to the hospital for hypo- or hyperglycemia; and
• HbA1C>6.5%.
• Patient underwent kidney transplantation at least six months before enrollment, and has stable kidney allograft function, defined as creatinine levels of maximum 2 mg/dl, stable renal allograft function as assessed by the transplant nephrologist, and has a creatinine clearance of more than 40 ml/min.
• Psychogenically able to comply, in the opinion of the investigator
• Female patients of childbearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion

You may not qualify if…

• Patient has previously received or is receiving an organ or bone marrow transplant other than a first kidney transplant.
• Patient has a known hypersensitivity to Tacrolimus, Sirolimus, Alemtuzumab, or Mycophenolate (allow substitution of Myfortic for CellCept).
• Patient is pregnant or lactating (must provide effective contraception method).
• Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment.
• Patient has participated in a trial involving a marketed drug or an infusion device within 30 days of the start of the trial.
• Patient exhibits any one of the following clinical criteria:
• Creatinine clearance or Glofil test < 40 mL/min
• Serum creatinine > 2.0 mg/dL consistently, or more than 0.2 mg/dl increase in creatinine over the last five months
• Body mass index > 28
• Malignancy other than BCC and SCC
• Radiographic evidence of pulmonary infection
• Evidence of liver disease as evidenced by >2X ULN for AST, ALT, Alk. Phos., or T. bili.
• Active infections
• Hypercoagulable states (history of recurrent venous thrombosis, defined thrombophilia)
• Bleeding / coagulation disorders
• Basal C-peptide > 0.3 ng/mL
• HbA1C >12%
• Insulin requirement > 1 IU/kg/day
• Seropositivity for HIV, HBV, HCV, HTLV-I
• Abnormal Pap smear, active gynecological infection
• Positive exercise or chemical cardiac tolerance test
• Patients currently under treatment for a medical condition requiring chronic use of steroids at a dose of prednisone >10 mg/day will be excluded.
• Substance/alcohol abuse
• Untreated proliferating diabetic retinopathy
• PPD conversion or positive PPD without INH if suspicious TB by chest X-ray or symptoms

Where it is running

• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.