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Clinical Trial Details

Trial ID: L1591
Source ID: NCT05216172
Associated Drug: Azd1656
Title: AZD1656 in Transplantation With Diabetes tO PromoTe Immune TOleraNce
Acronym: ADOPTION
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Diabetes Mellitus, Type 2|Renal Transplant|Kidney Transplant; Complications|End Stage Renal Disease
Interventions: DRUG: AZD1656|DRUG: Placebo
Outcome Measures: Primary: peripheral regulatory T cells, Change in mean peripheral Treg cell number between baseline and 3 months measured using flow cytometry analysis (FACS) in AZD1656 and placebo arms, 14 weeks | Secondary: regulatory T cells in renal transplant, Histological staining for Treg cells in renal biopsy tissue between baseline and 3 month protocol biopsy, 3 months|delayed graft function, Incidence of delayed graft function, defined as the need for dialysis within 1 week post-transplant, 1 week|glycemic control: HbA1c, Diabetic control between baseline and month 3 using change in HbA1c measurement, 3 months|number of participants with increase or decrease in concurrent anti-diabetic medication, Dose of other anti-diabetic medication between baseline and month 3 (descriptive), 3 months|incidence of treatment emergent adverse events, safety endpoints including hypoglycaemic episodes, 3 months|change in HOMA-IR measurement between baseline and month 3, Insulin resistance: HOMA IR measurement at month 3, 3 months|kidney transplant function, Graft function: (eGFR) at month 3, 3 months|kidney transplant rejection, Episodes of acute rejection (defined as biopsy proven acute rejection), 3 months|incidence of treatment emergent adverse events (with particular reference to episodes of infection), Episodes of opportunistic infections: bacterial and viral (descriptive), 3 months | Other: Comparison of patient and placebo group at 1 year post transplant: number of participants experiencing episodes of infection, rejection; comparison of renal function and diabetic control, 12-month graft function (eGFR) and diabetic control (HbA1c; medication review) to assess legacy effect, 1 year|T cell profile, Differences in other peripheral T cell populations, measured by FACS analysis, 3 months|regulatory T cells in renal transplant: biopsy for cause, Histological staining for Treg cells in any renal biopsy taken for clinical indications between baseline and month 3 protocol biopsy, 3 months|regulatory T cells: functional assay, Differences in the functional phenotype of the Treg cells, 3 months
Sponsor/Collaborators: Sponsor: Queen Mary University of London | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 26
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-12-13
Completion Date: 2022-09-11
Results First Posted:
Last Update Posted: 2024-06-20
Locations: Royal London Hospital Barts Health NHS Trust, London, E1 1BB, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05216172