Evidence map›Paper›PMID 28992127›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2018

Can we further enrich autosomal dominant polycystic kidney disease clinical trials for rapidly progressive patients? Application of the PROPKD score in the TEMPO trial.

Emilie Cornec-Le Gall, Jaime D Blais, Maria V Irazabal, Olivier Devuyst, Ron T Gansevoort, Ron D Perrone, Arlene B Chapman, Frank S Czerwiec, John Ouyang, Christina M Heyer and 4 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 8% 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

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic kidney disease: the TEMPO 4:4 Trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2018
    Trial
  4. Article
  5. End Point Selection in ADPKD Clinical Trials.Kidney international reports · 2025
    Review
  6. Article
  7. Integrated Use of Autosomal Dominant Polycystic Kidney Disease Prediction Tools for Risk Prognostication.Clinical journal of the American Society of Nephrology : CJASN · 2025
    Article
  8. Biomarkers of Kidney Disease Progression in ADPKD.Kidney international reports · 2024
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Overweight and Obesity and Progression of ADPKD.Clinical journal of the American Society of Nephrology : CJASN · 2021
    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

14 authors at 8 institutions in 4 countries.

Emilie Cornec-Le GallDivision of Nephrology and Hypertension, Mayo Clinic, Rochester, MN 55902, USA.
Jaime D BlaisOtsuka PDC, Rockville, MD, USA.
Maria V IrazabalDivision of Nephrology and Hypertension, Mayo Clinic, Rochester, MN 55902, USA.
Olivier DevuystInstitute of Nephrology, University of Zurich, Zurich, Switzerland.
Ron T GansevoortDepartment of Nephrology, University Medical Center of Groningen, Groningen, The Netherlands.
Ron D PerroneTufts Medical Center, Boston, MA, USA.
Arlene B ChapmanDivision of Nephrology, University of Chicago, Chicago, IL, USA.
Frank S CzerwiecOtsuka PDC, Rockville, MD, USA.
John OuyangOtsuka PDC, Rockville, MD, USA.
Christina M HeyerDivision of Nephrology and Hypertension, Mayo Clinic, Rochester, MN 55902, USA.
Sarah R SenumDivision of Nephrology and Hypertension, Mayo Clinic, Rochester, MN 55902, USA.
Yannick Le MeurEuropean University of Western Brittany, CHU Brest, Brest, France.
Vicente E TorresDivision of Nephrology and Hypertension, Mayo Clinic, Rochester, MN 55902, USA.
Peter C HarrisDivision of Nephrology and Hypertension, Mayo Clinic, Rochester, MN 55902, USA.
Mayo Clinic · USOtsuka (United States) · USHypertension Institute · USUniversité de Bretagne Occidentale · FRTufts Medical Center · USUniversity Medical Center Groningen · NLUniversity of Chicago · USUniversity of Zurich · CH

Funding

Pilot and FeasibilityP30DK090728 · NIDDK · MAYO CLINIC ROCHESTER · PI TORRES, VICENTE E · 2010 to 2019
$11.8M
RENIN ANGIOTENSIN SYSTEM IN THE PATHOGENESIS OF ADPKDR01DK044863 · NIDDK · MAYO CLINIC ROCHESTER · PI TORRES, VICENTE E · 1991 to 2019
$4.5M
NIDDK NIH HHS P30 DK090728NIDDK NIH HHS R01 DK044863
6 · The paper itself

Abstract

Background: The PROPKD score has been proposed to stratify the risk of progression to end-stage renal disease in autosomal dominant polycystic kidney disease (ADPKD) subjects. We aimed to assess its prognostic value in a genotyped subgroup of subjects from the Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (TEMPO3/4) trial. Methods: In the post hoc analysis, PKD1 and PKD2 were screened in 770 subjects and the PROPKD score was calculated in mutation-positive subjects (male: 1 point; hypertension <35 years: 2 points; first urologic event <35 years: 2 points; nontruncating PKD1 mutation: 2 points; truncating PKD1 mutation: 4 points). Subjects were classified into low-risk (LR; 0-3 points), intermediate-risk (IR; 4-6 points) and high-risk (HR; 7-9 points) groups. Results: The PROPKD score was calculated in 749 subjects (LR = 132, IR = 344 and HR = 273); age was inversely related to risk (LR = 43.6 years, IR = 39.5 years, HR = 36.2 years; P < 0.001). Subjects from the HR group had significantly higher height-adjusted total kidney volume (TKV) and rates of TKV growth. While baseline renal function was similar across all risk groups, the rate of estimated glomerular filtration rate (eGFR) decline significantly increased from LR to HR in the placebo group. Tolvaptan treatment effectiveness to reduce TKV growth was similar in all three risk categories. While tolvaptan significantly slowed eGFR decline in the IR (tolvaptan = -2.34 versus placebo = -3.33 mL/min/1.73 m2/year; P = 0.008) and HR groups (tolvaptan = -2.74 versus placebo = -3.94 mL/min/1.73 m2/year; P = 0.002), there was no difference in the LR group (tolvaptan = -2.35 versus placebo = -2.50 mL/min/1.73 m2/year; P = 0.72). Excluding the LR subjects from the analysis improved the apparent treatment effect of tolvaptan on eGFR decline. Conclusion: This study confirms the prognostic value of the PROPKD score and suggests that it could reduce costs and enhance endpoint sensitivity by enriching future study populations for rapidly progressing ADPKD subjects.

Indexed as

Severity of Illness IndexAdolescentAdultAge FactorsAntidiuretic Hormone Receptor AntagonistsClinical Trials as TopicDisease ProgressionFemaleGene RearrangementGlomerular Filtration RateHumansHypertensionKidneyMaleMiddle AgedPolycystic Kidney, Autosomal DominantAntidiuretic Hormone Receptor AntagonistsTolvaptanTRPP Cation Channels

Identifiers

PMID28992127
PMCPMC5888998
OpenAlexW2739027038

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

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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.