Intraportal or Intramuscular Site for Islets in Simultaneous Islet and Kidney Transplantation

Not Applicable

• Conditions: Type 1 Diabetes; End Stage Renal Disease

• Registration Number: NCT01967186
• Lead Sponsor: The Nordic Network For Clinical Islet Transplantation

Brief Summary

Islet transplantation is a promising treatment of type 1 diabetes in selected cases. Results are however hampered by a relatively low number of islets surviving the transplantation into the liver, which currently is the site for transplantation. In the present study we compare a new transplantation site (intramuscular in the arm) to the golden standard (the liver) in patients undergoing kidney transplantation from the same donor. In half of the intramuscular transplanted patients, the islets will be mixed with mesenchymal stemcells from the recipient to, possibly, improve the immunological aspects of the transplantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-22
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06
• Primary Completion: 2016-01
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Male and female patients age 18 to 65 years of age.
• Ability to provide written informed consent.
• Mentally stable and able to comply with the procedures of the study protocol.
• Clinical history compatible with type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years at the time of enrolment.
• Absence of stimulated C-peptide <0.1 nmol/L in response to a MMTT.
• All subjects must have received adequate medical treatment of their diabetes under the guidance from an experienced diabetologist.
• All subjects must have renal failure and be eligible for renal transplantation according to local criteria.

Exclusion Criteria

• Patients with prior organ transplants
• Patients that qualify for local simultaneous pancreas-kidney transplantation program and who prefer that option
• Patients with body mass index BMI > 28.
• Insulin requirement > 1 Unit/kg/day. If the patient is on peritoneal dialysis the same limit is set when the extra carbohydrates in the dialysis fluids have been accounted for.
• Consistently abnormal liver function tests ( > 1.5 x the upper limit of normal on two consecutive measurements > 2 weeks apart)
• Unstable diabetic retinopathy
• Hypercoagulability disorder or coagulopathy or International normalized ratio (INR)>1.5
• Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
• Patients with unstable cardiovascular status
• Patients with active infections, unless treatment is not judged necessary by the investigators
• Patients with serological evidence of infection with HIV, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
C-peptide derived from the Mixed Meal Tolerance Test (MMTT)	365 days (+/-14) after kidney transplantation	Percentage of patients in each study group reaching a systemic C-peptide derived from the MMTT above 0.1 nmol/L basal (fasting) and 90-min 0.3 nmol/L 75 (+/-5) and 365 days (+/-14) after kidney transplantation