Patry, Christian ORCID: 0000-0002-1270-6508, Sauer, Lukas D., Sander, Anja, Krupka, Kai, Fichtner, Alexander, Brezinski, Jolanda, Geissbuehler, Yvonne, Aubrun, Elodie, Grinienko, Anna, Dello Strologo, Luca, Haffner, Dieter, Oh, Jun, Grenda, Ryszard, Pape, Lars, Topaloglu, Rezan, Weber, Lutz T., Bouts, Antonia, Kim, Jon Jin, Prytula, Agnieszka ORCID: 0000-0001-9551-8758, Koenig, Jens, Shenoy, Mohan, Hoecker, Britta and Toenshoff, Burkhard (2023). Emulation of the control cohort of a randomized controlled trial in pediatric kidney transplantation with Real-World Data from the CERTAIN Registry. Pediatr. Nephrol., 38 (5). S. 1621 - 1633. NEW YORK: SPRINGER. ISSN 1432-198X

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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 m(2) P = 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Patry, ChristianUNSPECIFIEDorcid.org/0000-0002-1270-6508UNSPECIFIED
Sauer, Lukas D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sander, AnjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krupka, KaiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fichtner, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brezinski, JolandaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Geissbuehler, YvonneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aubrun, ElodieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grinienko, AnnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dello Strologo, LucaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haffner, DieterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oh, JunUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grenda, RyszardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pape, LarsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Topaloglu, RezanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weber, Lutz T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bouts, AntoniaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kim, Jon JinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Prytula, AgnieszkaUNSPECIFIEDorcid.org/0000-0001-9551-8758UNSPECIFIED
Koenig, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shenoy, MohanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoecker, BrittaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Toenshoff, BurkhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-695598
DOI: 10.1007/s00467-022-05777-x
Journal or Publication Title: Pediatr. Nephrol.
Volume: 38
Number: 5
Page Range: S. 1621 - 1633
Date: 2023
Publisher: SPRINGER
Place of Publication: NEW YORK
ISSN: 1432-198X
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
WEB-BASED REGISTRY; RENAL-TRANSPLANTATION; CHILDREN; BASILIXIMAB; ADOLESCENTSMultiple languages
Pediatrics; Urology & NephrologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69559

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