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Pancreas Transplant for Diabetic Kidney Disease in Type 1 Diabetes (PANCREAS Trial)
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.
PANCREAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPANCREAS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PANCREAS Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Isolated Pancreas Transplant
- Group 2: Intensive Insulin Therapy
- 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.
- 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.
Frequently Asked Questions
What are some potential risks associated with Isolated Pancreas Transplant?
"Isolated Pancreas Transplantation has been evaluated as a safe procedure by our team. It received a 3 on our safety scale, which corresponds to the fact that this is a Phase 3 trial with some efficacy data and multiple rounds of supportive safety data."
How can I sign up to be a part of this research?
"Applicants who meet the following criteria are eligible to participate in this clinical trial studying diabetic nephropathies: age between 25-55, no contraindications to pancreas transplant surgery, and evidence of poor diabetes control despite an optimized insulin regimen (continuous subcutaneous infusion or multiple daily injections)."
Could you please provide more context on previous Isolated Pancreas Transplant research?
"Currently, there are 80 different ongoing trials for Isolated Pancreas Transplant. Out of these, 13 have reached Phase 3. Most of the locations conducting these trials are based in Manhasset, New york; however, 257 research centres across the globe are researching this topic."
Are there any available slots for participants in this clinical trial?
"Unfortunately, this particular clinical trial is no longer admitting patients. The study was last active on June 1st, 2010. However, if you are still seeking a clinical trial to participate in, there are 298 trials currently recruiting for diabetic nephropathies and 80 studies for Isolated Pancreas Transplant that may be of interest."
Is this a large-scale or small-scale study?
"This particular clinical study has ceased searching for participants. However, if you are still interested in finding a trial to participate in, there are 298 trials for diabetic nephropathies and 80 trials for Isolated Pancreas Transplant that are currently recruiting patients."
Are elderly patients welcome in this trial?
"According to the study's eligibility requirements, patients must be aged between 25-55. There are 122 trials for patients under 18 and 219 for those over 65."
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