Evidence map›Paper›PMID 38355627›Full record

ArticleTrials2024

HYDROchlorothiazide versus placebo to PROTECT polycystic kidney disease patients and improve their quality of life: study protocol and rationale for the HYDRO-PROTECT randomized controlled trial.

Thomas Bais, Esther Meijer, Bart J Kramers, Priya Vart, Marc Vervloet, Mahdi Salih, Bert Bammens, Nathalie Demoulin, Polina Todorova, Roman-Ulrich Müller and 8 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. The long-term effect of tolvaptan treatment on kidney function and volume in patients with ADPKD.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Observational
  3. [Interpretation and Examples: Key Updates in SPIRIT 2025 Statement].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2025
    Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 13 institutions in 8 countries.

Thomas BaisDepartment of Nephrology, University Medical Center Groningen, Groningen, The Netherlands.
Esther MeijerDepartment of Nephrology, University Medical Center Groningen, Groningen, The Netherlands.ORCID http://orcid.org/0000-0001-7875-1793
Bart J KramersDepartment of Nephrology, University Medical Center Groningen, Groningen, The Netherlands.
Priya VartDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.
Marc VervloetDepartment of Nephrology, Amsterdam University Medical Centers, Location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Mahdi SalihDepartment of Internal Medicine, Division of Nephrology and Transplantation, Erasmus University Medical Center, Rotterdam, The Netherlands.
Bert BammensDepartment of Nephrology, Dialysis and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium.
Nathalie DemoulinDivision of Nephrology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Polina TodorovaUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department 2 for Internal Medicine, Cologne, Germany.
Roman-Ulrich MüllerUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department 2 for Internal Medicine, Cologne, Germany.
Jan HalbritterDepartment of Nephrology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Alexander PaliegeDepartment of Nephrology, Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Germany.
Emilie Cornec-Le GallUniversity Brest, Inserm, UMR 1078, GGB, Brest, 29609, France.
Bertrand KnebelmannDepartment of Nephrology, Necker-Enfants Malades Hospital AP-HP, Paris, France.
Roser TorraInherited Kidney Diseases, Nephrology Department, Fundació Puigvert, Institut d'Investigació Biomèdica Sant Pau (IIB-SANT PAU), Barcelona, Spain.
Albert C M OngAcademic Nephrology Unit, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.
Fiona E Karet FranklDepartment of Medical Genetics and Division of Renal Medicine, University of Cambridge, Cambridge, UK.
Ron T GansevoortDepartment of Nephrology, University Medical Center Groningen, Groningen, The Netherlands. r.t.gansevoort@umcg.nl.
University Medical Center Groningen · NLUniversity of Cologne · DECardiovascular Institute Hospital · JPCliniques Universitaires Saint-Luc · BEErasmus MC · NLHarvard University · USHôpital Necker-Enfants Malades · FRInserm · FRKU Leuven · BESheffield Teaching Hospitals NHS Foundation Trust · GBUniversitat Autònoma de Barcelona · ESUniversity Hospital Carl Gustav Carus · DEUniversity of Cambridge · GB

Funding

ZonMw 10140022010010
6 · The paper itself

Abstract

backgroundAutosomal dominant polycystic kidney disease (ADPKD) leads to progressive renal cyst formation and loss of kidney function in most patients. Vasopressin 2 receptor antagonists (V2RA) like tolvaptan are currently the only available renoprotective agents for rapidly progressive ADPKD. However, aquaretic side effects substantially limit their tolerability and therapeutic potential. In a preliminary clinical study, the addition of hydrochlorothiazide (HCT) to tolvaptan decreased 24-h urinary volume and appeared to increase renoprotective efficacy. The HYDRO-PROTECT study will investigate the long-term effect of co-treatment with HCT on tolvaptan efficacy (rate of kidney function decline) and tolerability (aquaresis and quality of life) in patients with ADPKD.

methodsThe HYDRO-PROTECT study is an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized clinical trial. The study is powered to enroll 300 rapidly progressive patients with ADPKD aged ≥ 18 years, with an eGFR of > 25 mL/min/1.73 m OUTCOMES: The primary study outcome is the rate of kidney function decline (expressed as eGFR slope, in mL/min/1.73 m

conclusionThe HYDRO-PROTECT study will demonstrate whether co-treatment with HCT can improve the renoprotective efficacy and tolerability of tolvaptan in patients with ADPKD.

Indexed as

Polycystic Kidney, Autosomal DominantAntidiuretic Hormone Receptor AntagonistsGlomerular Filtration RateHumansHydrochlorothiazideKidneyMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicTolvaptanAntidiuretic Hormone Receptor AntagonistsHydrochlorothiazideTolvaptan

Identifiers

PMID38355627
PMCPMC10865620
OpenAlexW4391831689

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.