Calcineurin Inhibitor-free, Steroid-free Immunosuppressive Regimen in Simultaneous Islet-Kidney Transplantation for Uremic Type 1 Diabetic Patients

NCT01033500 | Withdrawn DMC

• 1 other identifier: H-2010-0042
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that a calcineurin inhibitor-free, steroid-free, co-stimulatory blockade-based immunosuppressive regimen, in combination with a GLP-1 agonist, will reduce the islet mass required to achieve and sustain insulin independence following simultaneous islet-kidney transplantation.

Conditions

Islets of Langerhans Transplantation; Diabetes Mellitus, Type 1; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Achieve and consistently maintain insulin independence in simultaneous islet-kidney transplant recipients for one year.

  1 year

Study Arms (1)

SIK

EXPERIMENTAL

Basiliximab induction with maintenance immunosuppression consisting of belatacept, sirolimus or everolimus, and mycophenolate after simultaneous islet kidney transplantation.

Drug: Belatacept

Interventions

Belatacept DRUG

Belatacept 10mg/kg on Days 0, 4, 14, 28, 56, and 84 post-transplant, and then 5mg/kg every 4 weeks for the duration of the study.

SIK

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will include those with Type 1 Diabetes Mellitus, undergoing kidney transplantation, and:
• are closely followed by a primary care provider and/or endocrinologist for \>6 months prior to enrollment in the trial
• do not have psychogenic factors which preclude therapeutic compliance
• have a fasting C-peptide of \<0.2 ng/mL• have diabetes for \>5 years • are between 18 and 65 years of age
• have a creatinine clearance of less than 20 mL/min
• have a body mass index of less than or equal to 28
• In the case of women of childbearing potential (WOCBP), must have a negative pregnancy test and avoid pregnancy throughout the study and 8 weeks after final dose of study drug.
• WOCBP must use two adequate methods of contraception.
• A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 8 weeks after the last dose of study drug to minimize the risk of pregnancy.

You may not qualify if:

• Untreated proliferative diabetic retinopathy
• HgbA1C \>12
• creatinine clearance \> 20 ml/minute
• presence of panel reactive antibodies (PRA) \>20% (per CDC-based assay)
• malignancy or previous malignancy, except for adequately treated skin cancers (basal cell or squamous cell carcinoma) within the past 5 years
• sensitivity to iodine and/or shellfish (re: Iothalamate-based GFR testing)
• x-ray evidence of pulmonary infection
• active infections
• active peptic ulcer disease, gall stones, hemangioma, cirrhosis or portal hypertension
• serological evidence of HIV, HBSAg or HCV
• abnormal liver function tests (elevated AST and ALT \> 2x upper limit of normal)
• anemia (hemoglobin) \<9 gm/dl
• serum triglycerides \>200 mg/dl
• serum cholesterol \>240 mg/dl
• body mass index above 28

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Luis Fernandez, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: July 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

US (1)