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- Title
Emulation of the control cohort of a randomized controlled trial in pediatric kidney transplantation with Real-World Data from the CERTAIN Registry.
- Authors
Patry, Christian; Sauer, Lukas D.; Sander, Anja; Krupka, Kai; Fichtner, Alexander; Brezinski, Jolanda; Geissbühler, Yvonne; Aubrun, Elodie; Grinienko, Anna; Strologo, Luca Dello; Haffner, Dieter; Oh, Jun; Grenda, Ryszard; Pape, Lars; Topaloğlu, Rezan; Weber, Lutz T.; Bouts, Antonia; Kim, Jon Jin; Prytula, Agnieszka; König, Jens
- Abstract
Background: Randomized controlled trials in pediatric kidney transplantation are hampered by low incidence and prevalence of kidney failure in children. Real-World Data from patient registries could facilitate the conduct of clinical trials by substituting a control cohort. However, the emulation of a control cohort by registry data in pediatric kidney transplantation has not been investigated so far. Methods: In this multicenter comparative analysis, we emulated the control cohort (n = 54) of an RCT in pediatric kidney transplant patients (CRADLE trial; ClinicalTrials.gov NCT01544491) with data derived from the Cooperative European Paediatric Renal Transplant Initiative (CERTAIN) registry, using the same inclusion and exclusion criteria (CERTAIN cohort, n = 554). Results: Most baseline patient and transplant characteristics were well comparable between both cohorts. At year 1 posttransplant, a composite efficacy failure end point comprising biopsy-proven acute rejection, graft loss or death (5.8% ± 3.3% vs. 7.5% ± 1.1%, P = 0.33), and kidney function (72.5 ± 24.9 vs. 77.3 ± 24.2 mL/min/1.73 m2P = 0.19) did not differ significantly between CRADLE and CERTAIN. Furthermore, the incidence and severity of BPAR (5.6% vs. 7.8%), the degree of proteinuria (20.2 ± 13.9 vs. 30.6 ± 58.4 g/mol, P = 0.15), and the key safety parameters such as occurrence of urinary tract infections (24.1% vs. 15.5%, P = 0.10) were well comparable. Conclusions: In conclusion, usage of Real-World Data from patient registries such as CERTAIN to emulate the control cohort of an RCT is feasible and could facilitate the conduct of clinical trials in pediatric kidney transplantation.
- Subjects
EUROPE; RESEARCH; KIDNEY failure; URINARY tract infections; KIDNEY transplantation; PEDIATRICS; GRAFT survival; RANDOMIZED controlled trials; COMPARATIVE studies; PROTEINURIA; RESEARCH funding; CLINICAL trial registries; TRANSPLANTATION of organs, tissues, etc.; CHILDREN
- Publication
Pediatric Nephrology, 2023, Vol 38, Issue 5, p1621
- ISSN
0931-041X
- Publication type
Article
- DOI
10.1007/s00467-022-05777-x