Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Type 1 Diabetes (NCT03977662) | Clinical Trial Compass
CompletedPhase 1/2
Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Type 1 Diabetes
United States4 participantsStarted 2019-07-01
Plain-language summary
The primary objective is to test the hypothesis that co-transplantation of allogeneic PTG with adult pancreatic islets (derived from same deceased donor) in the IM site in people with Type 1 diabetes with functioning kidney and/or liver transplants is safe, allows islet engraftment, and leads to insulin independence.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female subjects age 18 or older.
✓. Subjects who are able to provide written informed consent and to comply with study procedures.
✓. Clinical history compatible with Type 1 diabetes (onset \< 40 yrs old and insulin dependent for \> 5 yrs at enrollment, c-peptide negative).
✓. Recipients should have absent stimulated c-peptide (\< 0.3 ng/mL) in response to a (Boost® 6 mL/kg BW to a maximum of 360 mL; another equivalent product), measured at 60 and 90 min after start of consumption.
✓. Subjects who are \> 6 months post-renal transplant or \>6 months post-liver transplant who are taking appropriate calcineurin inhibitor (CNI) based maintenance immunosuppression (\[tacrolimus alone or in conjunction with sirolimus, mycophenolate mofetil, myfortic, or azathioprine; or cyclosporine in conjunction with sirolimus, mycophenolate mofetil, or myfortic ± Prednisone ≤ 10 mg/day).
✓. Stable renal function as defined by a creatinine of no more than one third greater than the average creatinine determination performed in the 6 previous months prior to islet transplant, as well as absence of a rejection episode in the 6 months prior to islet transplant
✓. Stable liver function tests as defined by: SGOT (AST), SGPT (ALT), alkaline phosphatase values \< 1.5, or total bilirubin \< 1.5 times normal upper limits at time of study entry, as well as absence of a rejection episode in the 6 months prior to islet transplant
Exclusion criteria
✕. Presence of donor specific anti-HLA antibodies detected by Luminex Single Antigen/specificity bead assay including weakly reactive antibodies that would not be detected by a flow cross match
What they're measuring
1
Incidence of adverse events
Timeframe: Minimum of 1 year up to 2 years depending on transplant date
2
Incidence of post-transplant infections and malignancies
Timeframe: Minimum of 1 year up to 2 years depending on transplant date
3
Incidence of de novo sensitization
Timeframe: Minimum of 1 year up to 2 years depending on transplant date
4
Incidence of Insulin independence
Timeframe: Minimum of 1 year up to 2 years depending on transplant date
✕. Weight more than 100 kg or body mass index (BMI) \> 30 kg/m2.
✕. Primary hyperparathyroidism OR secondary hyperparathyroidism
✕. Untreated or unstable proliferative diabetic retinopathy.
✕. Blood Pressure: SBP \> 180 mmHg or DBP \>100 mmHg despite treatment with antihypertensive agents.
✕. Calculated GFR of ≤ 40 mL/min/1.73 m2 using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD- EPI) equation, as well as presence of a rejection episode in the 6 months prior to islet transplant
✕. Elevated liver function tests as defined by: SGOT (AST), SGPT (ALT), alkaline phosphatase values \> 1.5, or total bilirubin \>1.5 times normal upper limits at time of study entry, as well as presence of a rejection episode in the 6 months prior to islet transplant