Back to resultsIntraportal or Intramuscular Site for Islets in Simultaneous Islet and Kidney Transplantation
Primary Purpose
Type 1 Diabetes, End Stage Renal Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intraportal islet transplantation
Intramuscular islet transplantation
Intramuscular transpl with stemcells
Kidney transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, islets, transplantation, nephropathy, intramuscular
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Intraportal islet transplantation
Intramuscular islet transplantation
Intramuscular transpl with stemcells
Kidney transplantation only
Arm Description
Subject randomized to the protocol with intraportal islet transplantation and kidney transplantation
Subject randomized to the protocol with intramuscular islet transplantation and kidney transplantation
Subject randomized to the protocol with intramuscular islet transplantation and where islets have been incubated autologous mesenchymal stemcells. Will also receive kidney transplant
Subject that only undergoes kidney transplantation
Outcomes
Primary Outcome Measures
C-peptide derived from the Mixed Meal Tolerance Test (MMTT)
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01967186
First Posted
October 16, 2013
Last Updated
October 5, 2015
Sponsor
The Nordic Network For Clinical Islet Transplantation
1. Study Identification
Unique Protocol Identification Number
NCT01967186
Brief Title
Intraportal or Intramuscular Site for Islets in Simultaneous Islet and Kidney Transplantation
Official Title
Open Multi-Center Randomized Study to Compare Safety and Efficacy of Islet Transplantation Using The Intraportal or Intramuscular Site in Simultaneous Islet and Kidney Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Nordic Network For Clinical Islet Transplantation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, End Stage Renal Disease
Keywords
Type 1 diabetes, islets, transplantation, nephropathy, intramuscular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intraportal islet transplantation
Arm Type
Experimental
Arm Description
Subject randomized to the protocol with intraportal islet transplantation and kidney transplantation
Arm Title
Intramuscular islet transplantation
Arm Type
Experimental
Arm Description
Subject randomized to the protocol with intramuscular islet transplantation and kidney transplantation
Arm Title
Intramuscular transpl with stemcells
Arm Type
Experimental
Arm Description
Subject randomized to the protocol with intramuscular islet transplantation and where islets have been incubated autologous mesenchymal stemcells. Will also receive kidney transplant
Arm Title
Kidney transplantation only
Arm Type
Active Comparator
Arm Description
Subject that only undergoes kidney transplantation
Intervention Type
Procedure
Intervention Name(s)
Intraportal islet transplantation
Intervention Type
Procedure
Intervention Name(s)
Intramuscular islet transplantation
Intervention Type
Procedure
Intervention Name(s)
Intramuscular transpl with stemcells
Intervention Type
Procedure
Intervention Name(s)
Kidney transplantation
Intervention Description
All patients will undergo kidney transplantation regardless of arm
Primary Outcome Measure Information:
Title
C-peptide derived from the Mixed Meal Tolerance Test (MMTT)
Description
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
Time Frame
365 days (+/-14) after kidney transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaija Salmela, MD PhD
Organizational Affiliation
Kidney Transplant Unit, Helsinki University Hospital, Helsinki, Finland
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Intraportal or Intramuscular Site for Islets in Simultaneous Islet and Kidney Transplantation
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