Trial reportClinical and experimental nephrology2015
The effect of tolvaptan on autosomal dominant polycystic kidney disease patients: a subgroup analysis of the Japanese patient subset from TEMPO 3:4 trial.
Trial report in Clinical and experimental nephrology, 2015. 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 38 papers, 3 of them syntheses that pooled 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.
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.
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
Who cites it
38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- Interventions for preventing the progression of autosomal dominant polycystic kidney disease.The Cochrane database of systematic reviews · 2024Pooled it
- Efficacy and safety of tolvaptan versus placebo in the treatment of patients with autosomal dominant polycystic kidney disease: a meta-analysis.International urology and nephrology · 2023Pooled it
- The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019).Hypertension research : official journal of the Japanese Society of Hypertension · 2019Guideline
- Effect of tolvaptan in Japanese patients with autosomal dominant polycystic kidney disease: a post hoc analysis of TEMPO 3:4 and TEMPO Extension Japan.Clinical and experimental nephrology · 2021Trial
- Efficacy and safety of oral tolvaptan in patients undergoing hemodialysis: a Phase 2, double-blind, randomized, placebo-controlled trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 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
- Tolvaptan therapy of Chinese cirrhotic patients with ascites after insufficient diuretic routine medication responses: a phase III clinical trial.BMC gastroenterology · 2020Trial
- Nationwide epidemiological survey of autosomal dominant polycystic kidney disease in Japan in 2022.Clinical and experimental nephrology · 2026Article
- Evaluating the Safety and effectivenesS in adult KorEaN patients treated with Tolvaptan for management of autosomal domInAnt poLycystic kidney disease (ESSENTIAL): final report.Kidney research and clinical practice · 2026Article
- Long-Term Effects of Tolvaptan in Autosomal Dominant Polycystic Kidney Disease: Predictors of Treatment Response and Safety over 6 Years of Continuous Therapy.International journal of molecular sciences · 2024Article
- Public support for patients with intractable diseases in Japan: impact on clinical indicators from nationwide registries in patients with autosomal dominant polycystic kidney disease.Clinical and experimental nephrology · 2023Article
- Article
- Recent updates in therapeutic approach using tolvaptan for autosomal dominant polycystic kidney disease.The Korean journal of internal medicine · 2023Review
- Evaluating the Safety and effectivenesS in adult KorEaN patients treated with Tolvaptan for management of autosomal domInAnt poLycystic kidney disease (ESSENTIAL): short-term outcomes during the titration period.Kidney research and clinical practice · 2023Article
- A Systematic Review of Reported Outcomes in ADPKD Studies.Kidney international reports · 2022Article
- Long-Term Outcomes of Longitudinal Efficacy Study With Tolvaptan in ADPKD.Kidney international reports · 2022Article
- Clinical Utility and Tolerability of Tolvaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).Drug, healthcare and patient safety · 2022Review
- Safety and efficacy of Tolvaptan in real-world patients with autosomal dominant polycystic kidney disease- interim results of SLOW-PKD surveillance.Clinical and experimental nephrology · 2021Observational
- Comparison of annual eGFR decline among primary kidney diseases in patients with CKD G3b-5: results from a REACH-J CKD cohort study.Clinical and experimental nephrology · 2021Article
- IFT-A deficiency in juvenile mice impairs biliary development and exacerbates ADPKD liver disease.The Journal of pathology · 2021Article
Corrections and comments
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Authors and funding
9 authors at 8 institutions in 3 countries.
Funding
Abstract
backgroundJapan is the first country in the world to approve tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD), which was based on the results of Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) 3:4 trial. To evaluate the safety and efficacy of tolvaptan, we performed a subgroup analysis in the participating Japanese ADPKD patient population.
methodsThe primary outcome was the annual rate of percentage change in the total kidney volume (TKV). The secondary endpoint was the rate of kidney function change.
resultsThe tolvaptan and placebo groups included 118 and 59 patients, respectively. The annual rate of percentage changes in TKV were 1.3 % [95 % confidence interval (CI) 0.4-2.1] in the tolvaptan group, and 5.0 % (95 % CI 3.9-6.2) in the placebo group (P < 0.001). The annual estimated glomerular filtration rate change was -3.83 mL/min/1.73 m(2) in the tolvaptan group and -5.05 mL in the placebo group for a treatment effect of +1.22 mL/min/1.73 m(2) (95 % CI 0.41-2.02: P = 0.003). Hepatic function abnormal as a serious adverse event was observed in 3 patients (2.5 %) in the tolvaptan group.
conclusionsAdministration of tolvaptan in the Japanese sub-population reduced the annual rate of TKV growth and slowed the rate of kidney function decline over 36 months compared to patients on placebo, thus providing a novel and effective therapy for the treatment of ADPKD. (TEMPO 3:4 ClinicalTrials.gov number, NCT00428948).
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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.