Type 1 DiabetesPhase 3PANCREASNCT01067950
Pancreas Allotransplantation for Diabetic Nephropathy and Mild Chronic REnal fAilure Stage Study
A Phase 3 study testing Isolated Pancreas Transplant and Intensive Insulin Therapy in people with Type 1 Diabetes, run by Nantes University Hospital at 7 sites in 5 countries.
Trial summary
Current medical therapies are not able to prevent progression of established macroproteinuira (i.e. diabetic nephropathy) to end-stage renal failure in type 1 (insulin dependent) diabetic patients. In this setting, proteinuria is a major risk factor for mortality. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Isolated Pancreas Transplant and Intensive Insulin Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Mar 2010to not given
- Phase
- Phase 3
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be enroled in this study if they meet all of the following criteria:
- Type 1 diabetic patient aged between 25 and 55 years at the time of randomisation.
- Fasting plasma C-peptide below 0.5 ng/ml.
- Badly controlled diabetes despite an optimized insulin regimen consisting in continuous subcutaneous insulin infusion (via an insulin pump) or in multiple daily injections of insulin
- Persistent 24-hour proteinuria above 300 mg/day (a mean from 3 samples) despite adapted anti-proteinuric therapy for at least 6 months.
- Cystatin C and/or Cr51-EDTA and/or DMSA-Tc scintigraphy measured glomerular filtration rate from 60 to 90 ml/min.
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- No contraindication to pancreas transplant surgery
- Woman of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to maintain effective birth control during first year of the study.
- Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent has been obtained).
- Affiliated to national insurance.
Who cannot join
- Patients will be excluded from participating if any of the following criteria apply:
- Patient with any type 2 diabetes and/or fasting plasma C-peptide above 0.5 ng/ml.
- Pregnant woman or breast-feeding mothers.
- Woman of childbearing potential unwilling to maintain effective birth control during first year of the study
- Second transplant recipient or recipient with a functional grafted organ.
- Proteinuria below 300 mg/day (a mean from 3 samples).
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- Albuminemia less than 30 g/l.
- Cystatin C and/or Cr51-EDTA and/or DMSA-Tc scintigraphy measured glomerular filtration rate lower than 60 ml/min or higher than 90 ml/min.
- Presence of any documented non-diabetic systemic disease potentially affecting the kidney.
- Known allergy, hypersensibility or intolerance to any known insulin, to any of the recommended immunosuppressive agents of the study (Thymoglobulin, anti-lymphocyte serum Fresenius, tacrolimus, cyclosporin, mycophenolate mofetil, mycophenolic acid, corticosteroids etc), mocrolides antibiotics, or to any compound or excipient of all these products.
- Currently participating in another clinical trial and/or has taken an investigational drug within four weeks prior enrolment.
- Diagnosis of new-onset malignancy during 5 years before enrolment.
- Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
- Patient affected by active B hepatitis (HBsAg positive, HBeAg positive or HBV-DNA positive) or by active C hepatitis (HCVAb positive; HCV-RNA positive).
- Patient HIV positive.
- Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
- Obesity (body mass index above than 30 kg/m2).
- Severe iliac vessel calcifications impeding surgery.
- Advanced coronary artery disease
- Left ventricular function less than 30%.
- Plasma blood leukocytes less than 2,000 /mm3 or higher than 15,000/mm3
- Plasma blood platelets less 60,000 /mm3 or higher than 500,000/mm3
- Psychological disorders influencing drug compliance.
- Unable, unwilling or unlikely to comply fully with the protocol or the visits scheduled.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
France2 sites, 2 recruiting
- Recruiting
Hôpital Edouard-Herriot - Hospices Civils de Lyon
Lyon
Charles THIVOLET
- Recruiting
Centre Hospitalier et Universitaire de Nantes
Nantes
Diego CANTAROVICH, MD, PhD
Italy2 sites, 2 recruiting
- Not yet recruiting
Istituto Scientifico Ospedale San Raffaele
Milan
Antonio SECCHI
- Not yet recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa
Ugo BOGGI
United States1 site, 1 recruiting
- Not yet recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
David ER SUTHERLAND
Brazil1 site, 1 recruiting
- Not yet recruiting
Albert Einstein Jewish Hospital
São Paulo
Marcelo PEROSA
Czechia1 site, 1 recruiting
- Not yet recruiting
Diabetes Center - Institute for Clinical and Experimental Medicine
Prague
Frantisek SAUDEK
About this study
Official title: International, Multicenter, Prospective, Randomized, Parallel Group, Open Label Protocol to Evaluate Safety and Efficacy of Isolated Pancreas Transplantation Compared to Intensive Insulin Therapy in Type 1 Diabetic Patients With Overt Diabetic Nephropathy and Mildly Reduced Renal Function
Current medical therapies are not able to prevent progression of established macroproteinuira (i.e. diabetic nephropathy) to end-stage renal failure in type 1 (insulin dependent) diabetic patients. In this setting, proteinuria is a major risk factor for mortality. Pancreas transplantation, on the contrary, can revert diabetic nephropathy and thereby prevent end-stage chronic renal failure, with theoretically lower risk of death as compared to current medical therapies.The main objective of this study is to assess superiority of isolated pancreas transplantation versus intensive exogenous insulin therapy in type 1 diabetic patients with overt diabetic nephropathy and mildly reduced renal function. The primary endpoint is a composite efficacy/failure end-point including: patient mortality and renal function impairment during 5 years in patients with badly controlled diabetes and nephropathy resisting to up-to-date nephroprotective therapies.Main secondary objectives are safety and efficacy of both regimens, including proteinuria and renal histology evaluation, metabolic control and quality of life, acute and chronic extrarenal complications of diabetes, pancreas survival and all risks related to the transplant procedure (anaesthesia, surgery and immunosuppression side-effects) and to the intensive insulin therapy management.
- Conditions
- Type 1 Diabetes
- Being tested
- Isolated Pancreas Transplant, Intensive Insulin Therapy
- Keywords
- isolated pancreas transplant, intensive insulin therapy
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated Pancreas TransplantProcedure or surgery
Intensive Insulin TherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Isolated Pancreas Transplant | Experimental | Not described Receives: Procedure: Isolated Pancreas Transplant |
| Intensive Insulin Therapy | Active comparator | Not described Receives: Drug: Intensive Insulin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point is the 5-year evaluation of efficacy/failure rate, a composite end-point including: (i) patient mortality and (ii) renal function impairment
Measured: 5 years
Secondary outcomes (1)
Secondary objectives are to evaluate and to compare the safety and the efficacy of the two treatments (IPT versus IIT).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startMar 2010
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.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Diego CANTAROVICH, MD, PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067950
- Sponsor's protocol ID
- BRD 09/5-J
- Acronym
- PANCREAS
- Status last verified
- Mar 2010
- First submitted
- 11 Feb 2010
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Prospective, Randomized, Parallel Group, Open Label Protocol to Evaluate Safety and Efficacy of Isolated Pancreas Transplantation Compared to Intensive Insulin Therapy in Type 1 Diabetic Patients With Overt Diabetic Nephropathy and Mildly Reduced Renal Function
- ClinicalTrials.gov ID
- NCT01067950
- Acronym / sponsor ID
- PANCREAS / BRD 09/5-J
- Conditions
- Type 1 Diabetes
- Keywords
- isolated pancreas transplant, intensive insulin therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2010
- First posted
- 12 Feb 2010 (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.
Current medical therapies are not able to prevent progression of established macroproteinuira (i.e. diabetic nephropathy) to end-stage renal failure in type 1 (insulin dependent) diabetic patients. In this setting, proteinuria is a major risk factor for mortality. Pancreas transplantation, on the contrary, can revert diabetic nephropathy and thereby prevent end-stage chronic renal failure, with theoretically lower risk of death as compared to current medical therapies.The main objective of this study is to assess superiority of isolated pancreas transplantation versus intensive exogenous insulin therapy in type 1 diabetic patients with overt diabetic nephropathy and mildly reduced renal function. The primary endpoint is a composite efficacy/failure end-point including: patient mortality and renal function impairment during 5 years in patients with badly controlled diabetes and nephropathy resisting to up-to-date nephroprotective therapies.Main secondary objectives are safety and efficacy of both regimens, including proteinuria and renal histology evaluation, metabolic control and quality of life, acute and chronic extrarenal complications of diabetes, pancreas survival and all risks related to the transplant procedure (anaesthesia, surgery and immunosuppression side-effects) and to the intensive insulin therapy management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated Pancreas Transplant | Experimental | Procedure: Isolated Pancreas Transplant |
| Intensive Insulin Therapy | Active comparator | Drug: Intensive Insulin Therapy |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Type 1 diabetic patient aged between 25 and 55 years at the time of randomisation.
- Fasting plasma C-peptide below 0.5 ng/ml.
- Badly controlled diabetes despite an optimized insulin regimen consisting in continuous subcutaneous insulin infusion (via an insulin pump) or in multiple daily injections of insulin
- Persistent 24-hour proteinuria above 300 mg/day (a mean from 3 samples) despite adapted anti-proteinuric therapy for at least 6 months.
- Cystatin C and/or Cr51-EDTA and/or DMSA-Tc scintigraphy measured glomerular filtration rate from 60 to 90 ml/min.
Key exclusion criteria (24 listed)
- Patient with any type 2 diabetes and/or fasting plasma C-peptide above 0.5 ng/ml.
- Pregnant woman or breast-feeding mothers.
- Woman of childbearing potential unwilling to maintain effective birth control during first year of the study
- Second transplant recipient or recipient with a functional grafted organ.
- Proteinuria below 300 mg/day (a mean from 3 samples).
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 |
|---|---|---|
| Isolated Pancreas Transplant | Procedure or surgery | Isolated Pancreas Transplant |
| Intensive Insulin Therapy | Drug | Intensive Insulin Therapy |
Primary outcome
The primary end-point is the 5-year evaluation of efficacy/failure rate, a composite end-point including: (i) patient mortality and (ii) renal function impairment
Time frame: 5 years
1 secondary outcome
Secondary objectives are to evaluate and to compare the safety and the efficacy of the two treatments (IPT versus IIT).
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
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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.
Diego CANTAROVICH, MD, PhD principal investigator
Nantes University Hospital
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isolated Pancreas Transplant and Intensive Insulin Therapy in people with Type 1 Diabetes, run by Nantes University Hospital at 7 sites in 5 countries.
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 10 inclusion and 24 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 2 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Italy, United States, Brazil, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Diego CANTAROVICH, MD, PhD (+33(0)240087440, diego.cantarovich@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end-point is the 5-year evaluation of efficacy/failure rate, a composite end-point including: (i) patient mortality and (ii) renal function impairment (time frame: 5 years). 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 2 Jun 2010.