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yes no yes 122 0 VAAOTS+STIXMath-Regular Type 1C Custom yes yes yes 130 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2026-07-10 04:41:34 CEST RepresentationInformation: 329523.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2026-07-09 09:13:38 CEST Size: 1260999 Format: PDF Version: 1.4 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 414 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: ViewerPreferences: HideToolbar: false HideMenubar: false HideWindowUI: false FitWindow: false CenterWindow: false DisplayDocTitle: false NonFullScreenPageMode: UseNone Direction: L2R ViewArea: CropBox ViewClip: CropBox PrintArea: CropBox PageClip: CropBox PageLayout: SinglePage PageMode: UseOutlines Language: en-US Outlines: Item: Title: POINTER: study protocol for a phase 2b, randomised, placebo-controlled, double-blind, parallel group dose-finding clinical study to evaluate the efficacy of RMC-035 on renal function and safety, in participants at high risk for kidney injury, following op Children: Item: Title: Abstract Children: Item: Title: Background Item: Title: Methods Item: Title: Discussion Item: Title: Trial registration Item: Title: Administrative information Item: Title: Introduction Children: Item: Title: Background and rationale {6a} Item: Title: Objectives {7} Item: Title: Trial design {8} Item: Title: Methods: participants, interventions and outcomes Children: Item: Title: Study setting {9} Item: Title: Eligibility criteria {10} Item: Title: Who will take informed consent? {26a} Item: Title: Additional consent provisions for collection and use of participant data and biological specimens {26b} Item: Title: Interventions Children: Item: Title: Explanation for the choice of comparators {6b} Item: Title: Intervention description {11a} Item: Title: Criteria for discontinuing or modifying allocated interventions {11b} Item: Title: Strategies to improve adherence to interventions {11c} Item: Title: Relevant concomitant care permitted or prohibited during the trial {11d} Item: Title: Provisions for post-trial care {30} Item: Title: Outcomes {12} Children: Item: Title: Primary endpoint Item: Title: Key secondary endpoints Item: Title: Other secondary endpoints Item: Title: Exploratory endpoints Item: Title: Safety endpoints Item: Title: Participant timeline {13} Item: Title: Sample size {14} Item: Title: Recruitment {15} Item: Title: Assignment of interventions: allocation Children: Item: Title: Sequence generation {16a} Item: Title: Concealment mechanism {16b} Item: Title: Implementation {16c} Item: Title: Assignment of interventions: blinding Children: Item: Title: Who will be blinded {17a} Item: Title: Procedure for unblinding if needed {17b} Item: Title: Data collection and management Children: Item: Title: Plans for assessment and collection of outcomes {18a} Item: Title: Plans to promote participant retention and complete follow-up {18b} Item: Title: Data management {19} Item: Title: Confidentiality {27} Item: Title: Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trialfuture use {33} Item: Title: Statistical methods Children: Item: Title: Statistical methods for primary and secondary outcomes {20a} Children: Item: Title: Primary endpoint (main analytical approach) Item: Title: Key secondary endpoints (man analytical approach) Item: Title: Other secondary endpoints and exploratory endpoints Item: Title: Safety endpoints Item: Title: Interim analyses {21b} Item: Title: Methods for additional analyses (e.g. subgroup analyses) {20b} Children: Item: Title: Primary endpoint (sensitivity analyses) Item: Title: Key secondary endpoints (sensitivity analyses) Item: Title: Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} Item: Title: Plans to give access to the full protocol, participant level-data and statistical code {31c} Item: Title: Oversight and monitoring Children: Item: Title: Composition of the coordinating centre and trial steering committee {5d} Item: Title: Composition of the data monitoring committee, its role and reporting structure {21a} Item: Title: Adverse event reporting and harms {22} Item: Title: Frequency and plans for auditing trial conduct {23} Item: Title: Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} Item: Title: Dissemination plans {31a} Item: Title: Discussion Item: Title: Trial status Item: Title: Acknowledgements Item: Title: References Info: Title: POINTER: study protocol for a phase 2b, randomised, placebo-controlled, double-blind, parallel group dose-finding clinical study to evaluate the efficacy of RMC-035 on renal function and safety, in participants at high risk for kidney injury, following open-chest cardiac surgery Author: Alexander Zarbock Subject: Trials, 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protocol for a phase 2b, randomised, placebo-controlled, double-blind, parallel group dose-finding clinical study to evaluate the efficacy of RMC-035 on renal function and safety, in participants at high risk for kidney injury, following open-chest cardiac surgery Alexander Zarbock Christian Strauss Maxime Laflamme Andrej Myjavec Johannes Böhm Jan Burkert C. David Mazer Benoit de Varennes Antonino Ginel Iglesias Klaus Matschke Tobias E. 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