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Insulin Therapy
Pancreas Transplant for Diabetic Kidney Disease in Type 1 Diabetes (PANCREAS Trial)
Phase 3
Waitlist Available
Led By Diego CANTAROVICH, MD, PhD
Research Sponsored by Nantes University Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
PANCREAS Trial Summary
This trial is testing whether pancreas transplantation is better than current medical therapies at preventing end-stage renal failure in type 1 diabetic patients with overt diabetic nephropathy. The primary endpoint is a composite of patient mortality and renal function impairment after 5 years.
Who is the study for?
This trial is for type 1 diabetics aged 25-55 with poorly controlled diabetes despite optimized insulin therapy, persistent proteinuria above 300 mg/day, and mildly reduced renal function (GFR of 60-90 ml/min). They must not have other kidney-affecting diseases or severe health issues like heart failure, infections, blood disorders, or recent cancer. Women must use birth control during the study.Check my eligibility
What is being tested?
The study compares isolated pancreas transplantation to intensive insulin therapy in preventing kidney disease progression in type 1 diabetics. It looks at patient survival and kidney function over five years while also assessing safety and quality of life impacts.See study design
What are the potential side effects?
Potential side effects include those related to pancreas transplant surgery such as anesthesia risks, infection from immunosuppression drugs used to prevent organ rejection, and complications from diabetes management changes.
PANCREAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diabetes is not well-managed despite using an insulin pump or multiple daily injections.
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I have had high protein levels in my urine for over 6 months despite treatment.
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My kidney function, measured by specific tests, is within the normal range.
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I am medically cleared for pancreas transplant surgery.
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I am between 25 and 55 years old and have Type 1 diabetes.
PANCREAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Secondary objectives are to evaluate and to compare the safety and the efficacy of the two treatments (IPT versus IIT).
PANCREAS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Isolated Pancreas TransplantExperimental Treatment1 Intervention
Group II: Intensive Insulin TherapyActive Control1 Intervention
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Who is running the clinical trial?
Nantes University HospitalLead Sponsor
762 Previous Clinical Trials
7,023,803 Total Patients Enrolled
Diego CANTAROVICH, MD, PhDPrincipal InvestigatorNantes University Hospital
1 Previous Clinical Trials
193 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to certain insulins, immunosuppressants, antibiotics, or their ingredients.You have a low amount of protein in your urine, less than 300 milligrams per day based on multiple samples.My heart's left ventricle is functioning below 30%.My diabetes is not well-managed despite using an insulin pump or multiple daily injections.Your blood has too few or too many white blood cells.I was diagnosed with cancer within the last 5 years.I have active hepatitis B or C.You have HIV.I have severe calcification in my iliac vessels that makes surgery difficult.I have had high protein levels in my urine for over 6 months despite treatment.My kidney function is either below 60 ml/min or above 90 ml/min.I have received a second transplant or my transplanted organ is working well.You have mental health conditions that may make it difficult for you to take the medication as prescribed.I have type 2 diabetes or my fasting C-peptide level is above 0.5 ng/ml.Your blood albumin levels are less than 30 g/l.I have severe heart artery disease.My BMI is over 30.My kidney function, measured by specific tests, is within the normal range.Your fasting plasma C-peptide level is less than 0.5 ng/ml.I understand the study's risks and have signed the consent form.Your blood platelet count is below 60,000/mm3 or above 500,000/mm3.I have a non-diabetic condition that could affect my kidneys.I do not have severe infections, diarrhea, vomiting, or stomach issues.I am medically cleared for pancreas transplant surgery.I am between 25 and 55 years old and have Type 1 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Isolated Pancreas Transplant
- Group 2: Intensive Insulin Therapy
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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