Trial reportJournal of the American Society of Nephrology : JASN2017
Urine Osmolality, Response to Tolvaptan, and Outcome in Autosomal Dominant Polycystic Kidney Disease: Results from the TEMPO 3:4 Trial.
Trial report in Journal of the American Society of Nephrology : JASN, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03717883 (Endogenous Molecule Profiling in Subjects With Autosomal Dominant Polycystic Kidney Disease), which is not on this map. Cited by 61 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
Endogenous Molecule Profiling in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Who cites it
61 citing papers in PubMed, 3 syntheses or guidelines pooled it, 97 citations in OpenAlex.
- Serum and urine prognostic biomarkers for autosomal dominant polycystic kidney disease: a systematic review and meta-analysis.BMC nephrology · 2026Pooled it
- Interventions for preventing the progression of autosomal dominant polycystic kidney disease.The Cochrane database of systematic reviews · 2024Pooled it
- Tolvaptan add-on therapy and its effects on efficacy parameters and outcomes in patients hospitalized with heart failure.Indian heart journalPooled it
- Change in kidney volume growth rate and renal outcomes of tolvaptan treatment in autosomal dominant polycystic kidney disease: post-hoc analysis of TEMPO 3:4 trial.Clinical and experimental nephrology · 2025Trial
- Effects of salt and protein intake on polyuria in V2RA-treated ADPKD patients.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2024Trial
- The effect of trichlormethiazide in autosomal dominant polycystic kidney disease patients receiving tolvaptan: a randomized crossover controlled trial.Scientific reports · 2021Trial
- Preservation of kidney function irrelevant of total kidney volume growth rate with tolvaptan treatment in patients with autosomal dominant polycystic kidney disease.Clinical and experimental nephrology · 2021Trial
- Autosomal-dominant polycystic kidney disease: tolvaptan use in adolescents and young adults with rapid progression.Pediatric research · 2021Trial
- High water vs. ad libitum water intake for autosomal dominant polycystic kidney disease: a randomized controlled feasibility trial.QJM : monthly journal of the Association of Physicians · 2020Trial
- Plasma copeptin levels predict disease progression and tolvaptan efficacy in autosomal dominant polycystic kidney disease.Kidney international · 2019Trial
- Octreotide-LAR in later-stage autosomal dominant polycystic kidney disease (ALADIN 2): A randomized, double-blind, placebo-controlled, multicenter trial.PLoS medicine · 2019Trial
- A new frontier in edema management: the potential of tolvaptan for refractory edema with hyponatremia in pediatric nephrotic syndrome.Clinical and experimental nephrology · 2026Article
- Paradoxical Hyponatremia on High-Dose Tolvaptan in ADPKD.Kidney international reports · 2026Article
- The Relationship of Osmolality and Kidney Outcomes in Patients with Autosomal Dominant Polycystic Kidney Disease.Kidney360 · 2026Article
- Canadian Society of Nephrology Commentary on the 2025 Kidney Disease Improving Global Outcomes Clinical Practice Guidelines for Autosomal Dominant Polycystic Kidney Disease.Canadian journal of kidney health and disease · 2026Article
- KDIGO 2025 Autosomal Dominant Polycystic Kidney Disease Guidelines: Real-World Perspectives on Nomenclature, Tolvaptan Use, and Polycystic Liver Disease.Clinical journal of the American Society of Nephrology : CJASN · 2026Article
- 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 · 2025Observational
- Spot Versus 24-Hour Urine Osmolality Measurement in Autosomal Dominant Polycystic Kidney Disease: A Diagnostic Test Study.Kidney medicine · 2025Article
- Commentary: Tolvaptan for Autosomal Dominant Polycystic Kidney Disease (ADPKD) - an update.BMC nephrology · 2025Review
- Autosomal Dominant Polycystic Kidney Disease Inflammation Biomarkers in the Tolvaptan Era.International journal of molecular sciences · 2025Review
1 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 8 institutions in 4 countries.
Funding
Abstract
The vasopressin-cAMP-osmolality axis is abnormal in autosomal dominant polycystic kidney disease (ADPKD). In the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes 3:4 Trial, a 3-year randomized, placebo-controlled trial in adults, the vasopressin V2 receptor antagonist tolvaptan slowed ADPKD progression in patients with preserved GFR. Here, we investigated the determinants of baseline urine osmolality (Uosm) and its value as a severity marker of ADPKD, the factors influencing the response to tolvaptan, and whether change in Uosm associated with key trial end points. At baseline, lower Uosm independently associated with female sex, presence of hypertension, lower eGFR, higher total kidney volume (TKV), and higher age. Tolvaptan consistently reduced Uosm by 200-300 mOsm/kg over 36 months. The Uosm response to tolvaptan depended on baseline eGFR and Uosm. Subjects with greater change in Uosm experienced a significant reduction in clinical progression events. Among subjects receiving tolvaptan, those with a greater suppression of Uosm had slower renal function decline. Assessment at follow-up, off medication, revealed a significant decrease in Uosm in both placebo and treated groups. Tolvaptan significantly increased plasma osmolality, which returned to baseline at follow-up. In conclusion, baseline Uosm in ADPKD reflects age, renal function, and TKV, and baseline Uosm, eGFR, and TKV influence the effect of tolvaptan on Uosm. The greatest renal benefit occurred in subjects achieving greater suppression of Uosm, that is, those with better eGFR at baseline. These results support the link between vasopressin V2 receptor signaling and ADPKD progression.
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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.