Type 1 DiabetesNCT01967186
Intraportal or Intramuscular Site for Islets in Simultaneous Islet and Kidney Transplantation
A study testing Intraportal islet transplantation, Intramuscular islet transplantation and Intramuscular transpl with stemcells in people with Type 1 Diabetes and End Stage Renal Disease, run by The Nordic Network For Clinical Islet Transplantation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, End Stage Renal Disease
- What is being tested?
- Intraportal islet transplantation, Intramuscular islet transplantation and Intramuscular transpl with stemcells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Jul 2016
- 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
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
About this study
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
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.
- Conditions
- Type 1 Diabetes, End Stage Renal Disease
- Being tested
- Intraportal islet transplantation, Intramuscular islet transplantation, Intramuscular transpl with stemcells, Kidney transplantation
- Keywords
- Type 1 diabetes, islets, transplantation, nephropathy, intramuscular
- Medical subject headings
- Diabetes Mellitus, Type 1, Kidney Failure, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraportal islet transplantationProcedure or surgery
Intramuscular islet transplantationProcedure or surgery
Intramuscular transpl with stemcellsProcedure or surgery
Kidney transplantationProcedure or surgery
All patients will undergo kidney transplantation regardless of arm
| Study group | Role | What they receive |
|---|---|---|
| Intraportal islet transplantation | Experimental | Subject randomized to the protocol with intraportal islet transplantation and kidney transplantation Receives: Procedure: Intraportal islet transplantation; Procedure: Kidney transplantation |
| Intramuscular islet transplantation | Experimental | Subject randomized to the protocol with intramuscular islet transplantation and kidney transplantation Receives: Procedure: Intramuscular islet transplantation; Procedure: Kidney transplantation |
| Intramuscular transpl with stemcells | Experimental | Subject randomized to the protocol with intramuscular islet transplantation and where islets have been incubated autologous mesenchymal stemcells. Will also receive kidney transplant Receives: Procedure: Intramuscular transpl with stemcells; Procedure: Kidney transplantation |
| Kidney transplantation only | Active comparator | Subject that only undergoes kidney transplantation Receives: Procedure: Kidney transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 365 days (+/-14) after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startApr 2007
- Primary completionJan 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Nordic Network For Clinical Islet Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaija Salmela, MD PhD, Principal investigator, Kidney Transplant Unit, Helsinki University Hospital, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967186
- Sponsor's protocol ID
- SIK01
- Status last verified
- Oct 2015
- First submitted
- 16 Oct 2013
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01967186
- Acronym / sponsor ID
- SIK01
- Conditions
- Type 1 Diabetes, End Stage Renal Disease
- Keywords
- Type 1 diabetes, islets, transplantation, nephropathy, intramuscular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Nordic Network For Clinical Islet TransplantationUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intraportal islet transplantation | Experimental | Procedure: Intraportal islet transplantation, Procedure: Kidney transplantationSubject randomized to the protocol with intraportal islet transplantation and kidney transplantation |
| Intramuscular islet transplantation | Experimental | Procedure: Intramuscular islet transplantation, Procedure: Kidney transplantationSubject randomized to the protocol with intramuscular islet transplantation and kidney transplantation |
| Intramuscular transpl with stemcells | Experimental | Procedure: Intramuscular transpl with stemcells, Procedure: Kidney transplantationSubject randomized to the protocol with intramuscular islet transplantation and where islets have been incubated autologous mesenchymal stemcells. Will also receive kidney transplant |
| Kidney transplantation only | Active comparator | Procedure: Kidney transplantationSubject that only undergoes kidney transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraportal islet transplantation | Procedure or surgery | Intraportal islet transplantation |
| Intramuscular islet transplantation | Procedure or surgery | Intramuscular islet transplantation |
| Intramuscular transpl with stemcells | Procedure or surgery | Intramuscular transpl with stemcells |
| Kidney transplantationAll patients will undergo kidney transplantation regardless of arm | Procedure or surgery | Intramuscular islet transplantation, Intramuscular transpl with stemcells, Intraportal islet transplantation, Kidney transplantation only |
Primary outcome
C-peptide derived from the Mixed Meal Tolerance Test (MMTT)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaija Salmela, MD PhD principal investigator
Kidney Transplant Unit, Helsinki University Hospital, Helsinki, Finland
Questions about this trial
What is this clinical trial studying?
A study testing Intraportal islet transplantation, Intramuscular islet transplantation and Intramuscular transpl with stemcells in people with Type 1 Diabetes and End Stage Renal Disease, run by The Nordic Network For Clinical Islet Transplantation.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
C-peptide derived from the Mixed Meal Tolerance Test (MMTT) (time frame: 365 days (+/-14) after kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2015.