Trials / Unknown
UnknownNCT05662267
Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Kidney Transplant Recipient.
Targeted Trial Emulation of Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Transplant Recipients : a French Nationwide Cohort Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Islet transplantation is associated with a benefit on glycaemic control compared to optimized insulin therapy in recent clinical trials. However, there is a lack of evidence concerning the long-term impact of islet transplantation on type 1 diabetic kidney transplant recipients' prognosis. The objective of the study is to assess the impact of islet transplantation in patients with type 1 diabetes and a kidney transplantation on the risk of graft failure. Every type 1 diabetic recipient transplanted with a kidney in France between 2000 and 2017 is included. Patients transplanted with pancreatic islets are compared to controls treated with insulin alone according to a matching method based on time-dependent propensity scores which allow to ensure patients comparability at the time of islet transplantation. Time-dependent propensity scores are built according to variables associated with both the probabilities of being transplanted with islets and the outcome of interest. These variables are assessed by a direct acyclic graph. The primary outcome consists in death-uncensored graft survival, defined by death or return to dialysis. Secondary outcomes include the risk of death, or the risk of death-censored graft survival.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Pancreatic islet transplantation after kidney transplantation | Pancreatic islet transplantation consists in the intrahepatic transplantation of pancreatic islets, as a result of enzymatic digestion of a deceased-donor pancreas. |
Timeline
- Start date
- 2020-03-10
- Primary completion
- 2023-03-01
- Completion
- 2023-03-01
- First posted
- 2022-12-22
- Last updated
- 2022-12-22
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05662267. Inclusion in this directory is not an endorsement.