Evidence map›Paper›PMID 33912753›Full record

ArticleKidney international reports2021

Per-Treatment

Andrew J Mallett, Ronald D Perrone, Gopala Rangan, Carmel Hawley, Ragada El-Damanawi, Thomas F Hiemstra, Carolina Townsend Arellano, Jennifer Lee, Vicente E Torres

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Kidney international reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT00428948 phase3completednot on this map

A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2007 to 2012Enrolled1,445ConditionsPolycystic Kidney Disease, Autosomal DominantArmsTolvaptan, Placebo
NCT02160145 phase3completednot on this map

A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2014 to 2017Enrolled1,370ConditionsChronic Kidney Disease, Autosomal Dominant Polycystic Kidney DiseaseArmsTolvaptan (OPC-41061), Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Andrew J MallettInstitute for Molecular Bioscience and Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.
Ronald D PerroneDivision of Nephrology, Department of Medicine, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts, USA.
Gopala RanganCentre for Transplant and Renal Research, Westmead Institute for Medical Research, The University of Sydney, Sydney, New South Wales, Australia.
Carmel HawleyDepartment of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.
Ragada El-DamanawiDivision of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge, UK.
Thomas F HiemstraDivision of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge, UK.
Carolina Townsend ArellanoInstitute for Molecular Bioscience and Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.
Jennifer LeeBiostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.
Vicente E TorresDivision of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn pivotal trials of patients with autosomal dominant polycystic kidney disease at risk of rapid progression, tolvaptan slowed estimated glomerular filtration rate (eGFR) decline in early-to-moderate (TEMPO 3:4 [NCT00428948]) and moderate- to late-stage (REPRISE [NCT02160145]) chronic kidney disease (CKD). Discontinuation was less frequent in REPRISE (15.0%) than TEMPO 3:4 (23.0%), given that in REPRISE, only subjects who tolerated tolvaptan 60/30 mg daily initiated the double-blind phase. We evaluated whether the greater treatment effect in REPRISE was attributable to different completion rates.

methodsWe conducted

resultsThe annualized tolvaptan treatment effect in TEMPO 3:4 completers (difference vs. placebo of 0.98 ml/min per 1.73 m

conclusionGreater treatment completion rate did not drive greater treatment effect in REPRISE. The more advanced CKD of REPRISE subjects may be more relevant. More rapid decline in kidney function in later-stage CKD enabled the effects of tolvaptan to be more easily discerned.

Indexed as

autosomal dominant polycystic kidney diseasechronic kidney diseaseclinical trialpersistencetolvaptantreatment effect

Identifiers

PMID33912753
PMCPMC8071614

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Registered trials

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.