Evidence map›Paper›PMID 33471240›Full record

Trial reportClinical and experimental nephrology2021

Preservation of kidney function irrelevant of total kidney volume growth rate with tolvaptan treatment in patients with autosomal dominant polycystic kidney disease.

Shigeo Horie, Satoru Muto, Haruna Kawano, Tadashi Okada, Yoshiyuki Shibasaki, Koji Nakajima, Tatsuki Ibuki

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical and experimental nephrology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00428948 (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), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 7% 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.

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
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Biomolecules · 2023
    Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Review
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

7 authors at 2 institutions in 1 country.

Shigeo HorieDepartment of Urology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan. shorie@juntendo.ac.jp.ORCID http://orcid.org/0000-0002-8612-8368
Satoru MutoDepartment of Urology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
Haruna KawanoDepartment of Urology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
Tadashi OkadaDepartment of Clinical Development, Otsuka Pharmaceutical Co., Ltd, Osaka, Japan.
Yoshiyuki ShibasakiMedical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.
Koji NakajimaMedical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.
Tatsuki IbukiMedical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.
Otsuka (Japan) · JPJuntendo University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTolvaptan slowed the rates of total kidney volume (TKV) growth and renal function decline over a 3-year period in patients with autosomal dominant polycystic kidney disease (ADPKD) enrolled in the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) 3:4 trial (NCT00428948). In this post hoc analysis of Japanese patients from TEMPO 3:4, we evaluated whether the effects of tolvaptan on TKV and on renal function are interrelated.

methodsOne hundred and forty-seven Japanese patients from TEMPO 3:4 were included in this analysis (placebo, n = 55; tolvaptan, n = 92). Tolvaptan-treated patients were stratified into the responder group (n = 37), defined as tolvaptan-treated patients with a net decrease in TKV from baseline to year 3, and the non-responder group (n = 55), defined as tolvaptan-treated patients with a net increase in TKV.

resultsMean changes during follow-up in the placebo, responder, and non-responder groups were 16.99%, - 8.33%, and 13.95%, respectively, for TKV and - 12.61, - 8.47, and - 8.58 mL/min/1.73 m

conclusionTolvaptan was effective in slowing eGFR decline, regardless of TKV response, over 3 years in patients with ADPKD in Japan. Treatment with tolvaptan may have beneficial effects on slowing of renal function decline even in patients who have not experienced a reduction in the rate of TKV growth by treatment with tolvaptan.

Indexed as

AdultAntidiuretic Hormone Receptor AntagonistsBody HeightBody Mass IndexBody WeightDouble-Blind MethodFemaleGlomerular Filtration RateHumansKidneyMaleMiddle AgedOrgan SizeOsmolar ConcentrationPolycystic Kidney, Autosomal DominantSex FactorsAntidiuretic Hormone Receptor AntagonistsTolvaptanAutosomal dominant polycystic kidney diseaseGlomerular filtration rateJapanTolvaptanTotal kidney volume

Identifiers

PMID33471240
PMCPMC8038960
OpenAlexW3121982663

What OpenQuestion holds

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LicenceCC BY
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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.