Statin therapy in patients with early-stage autosomal dominant polycystic kidney disease: Design and baseline characteristics.

Autor: Gitomer BY; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA. Electronic address: Berenice.gitomer@cuanschutz.edu., Wang W; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA. Electronic address: wei.wang@cuanschutz.edu., George D; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA. Electronic address: diana.george@cuanschutz.edu., Coleman E; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA. Electronic address: erin.coleman@cuanschutz.edu., Nowak KL; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA. Electronic address: kristen.nowak@cuanschutz.edu., Struemph T; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA. Electronic address: taylor.struemph@cuanschutz.edu., Cadnapaphornchai MA; Rocky Mountain Pediatric Kidney Center, Rocky Mountain Hospital for Children at Presbyterian/St. Luke's Medical Center, 2055 N. High St., Suite 205, Denver, CO 80205, USA., Patel NU; Department of Radiology, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA. Electronic address: NaUPatel@salud.unm.edu., Jovanovich A; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA; VA Eastern Colorado Healthcare System, Aurora, CO, USA. Electronic address: anna.jovanovich@cuanschutz.edu., Klawitter J; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA. Electronic address: jelena.klawitter@cuanschutz.edu., Farmer B; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA. Electronic address: beverly.farmer@cuanschutz.edu., Ostrow A; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA. Electronic address: anna.ostrow@cuanschutz.edu., You Z; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA. Electronic address: zhiying.you@cuanschutz.edu., Chonchol M; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, 13199 East Montview Blvd., Suite 495, Aurora, CO 80045, USA. Electronic address: michel.chonchol@cuanschutz.edu.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2024 Feb; Vol. 137, pp. 107423. Date of Electronic Publication: 2023 Dec 25.
DOI: 10.1016/j.cct.2023.107423
Abstrakt: Background: Autosomal dominant polycystic kidney disease (ADPKD) is characterized by the development and continued growth of multiple cysts in the kidneys leading to ultimate loss of kidney function in most patients. Currently, tolvaptan is the only agency approved therapy to slow kidney disease advancement in patients with faster progressing disease underscoring the need for additional ADPKD therapies suitable for all patients. We previously showed that pravastatin slowed kidney disease progression in children and young adults with ADPKD. However, the intervention has not been tested in an adult cohort.
Aims: The aim of the study is to conduct a single center, randomized, placebo-controlled double-blinded clinical trial to determine the efficacy of pravastatin on slowing kidney disease progression in adult patients with early stage ADPKD.
Methods: One hundred and fifty adult patients with ADPKD and eGFR ≥60 ml/min/1.73m 2 will be enrolled in the study and randomized to receive 40 mg/day pravastatin or placebo for a period of 2-years.
Outcomes: The primary outcome of the trial is change in total kidney volume assessed by magnetic resonance imaging (MRI). Secondary outcomes include change in kidney function by iothalamate GFR and renal blood flow and markers of inflammation and oxidative stress.
Conclusion: This study will assess the kidney therapeutic benefits of pravastatin in adult patients with ADPKD. The recruitment goal of 150 subjects was attained and the study is ongoing.
Registration: This study is registered on Clinicaltrials.gov # NCT03273413.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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