Trial reportKidney international2014
Pharmacokinetics and pharmacodynamics of oral tolvaptan in patients with varying degrees of renal function.
Trial report in Kidney international, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 41 citations in OpenAlex.
- Low-dose tolvaptan PK/PD: comparison of patients with hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion to healthy adults.European journal of clinical pharmacology · 2017Trial
- Pharmacokinetics and Pharmacodynamics of Tolvaptan in Autosomal Dominant Polycystic Kidney Disease: Phase 2 Trials for Dose Selection in the Pivotal Phase 3 Trial.Journal of clinical pharmacology · 2017Trial
- Urine Osmolality, Response to Tolvaptan, and Outcome in Autosomal Dominant Polycystic Kidney Disease: Results from the TEMPO 3:4 Trial.Journal of the American Society of Nephrology : JASN · 2017Trial
- Dual Impact of Tolvaptan on Intracellular and Extracellular Water in Chronic Kidney Disease Patients with Fluid Retention.Internal medicine (Tokyo, Japan)Trial
- Effect of Severe Renal Impairment on Dordaviprone (ONC201) Pharmacokinetics.Drugs in R&D · 2025Article
- Pharmacotherapy in kidney disease: what it takes to move from general guidance to specific recommendations to stratified subgroups of patients - the tale of autosomal dominant polycystic kidney disease (ADPKD).Expert opinion on drug metabolism & toxicology · 2025Review
- Tolvaptan safety in autosomal-dominant polycystic kidney disease; a focus on idiosyncratic drug-induced liver injury liabilities.Toxicological sciences : an official journal of the Society of Toxicology · 2025Review
- Identifying the main predictors of urine output in autosomal-dominant polycystic kidney disease (ADPKD) patients taking tolvaptan.International urology and nephrology · 2023Article
- Evaluation of Renal Impairment Influence on Metabolic Drug Clearance using a Modelling Approach.Clinical pharmacokinetics · 2023Article
- Efficacy of oral tolvaptan for severe edema and hyponatremia in a patient with refractory nephrotic syndrome.CEN case reports · 2021Article
- Model-Based Comparative Analysis of Rifampicin and Rifabutin Drug-Drug Interaction Profile.Antimicrobial agents and chemotherapy · 2021Article
- Congestion in heart failure: a contemporary look at physiology, diagnosis and treatment.Nature reviews. Cardiology · 2020Review
- Impact of serum albumin levels on the body fluid response to tolvaptan in chronic kidney disease patients.International urology and nephrology · 2019Article
- Review
- Tolerability of Aquaretic-Related Symptoms Following Tolvaptan for Autosomal Dominant Polycystic Kidney Disease: Results From TEMPO 3:4.Kidney international reports · 2017Article
- Unveiling some FDA-approved drugs as inhibitors of the store-operated CaScientific reports · 2017Article
- Effect of tolvaptan in a patient with autosomal dominant polycystic kidney disease after living donor liver transplantation.CEN case reports · 2016Article
- Risk factors for hypernatremia in patients with short- and long-term tolvaptan treatment.European journal of clinical pharmacology · 2016Observational
- Inhibition of Human Hepatic Bile Acid Transporters by Tolvaptan and Metabolites: Contributing Factors to Drug-Induced Liver Injury?Toxicological sciences : an official journal of the Society of Toxicology · 2016Article
- Review
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The selective vasopressin V2-receptor antagonist tolvaptan is eliminated almost exclusively by non-renal mechanisms. As renal impairment can influence the pharmacokinetics of drugs even when eliminated by non-renal mechanisms, we evaluated the effect of renal insufficiency on the pharmacokinetics/pharmacodynamics of tolvaptan. Thirty-seven patients were grouped by a 24-h creatinine clearance (CrCL) and evaluated for 48 h after a single 60 mg oral dose in the fasting state. Mean tolvaptan exposure was 90% higher in the under 30-ml/min group compared with the over 60-ml/min group with individual values significantly but negatively correlated with increasing baseline CrCL. There was a greater and more rapid increase in urine output and free water clearance in the over 60-ml/min compared with the renal impaired groups, but they returned to baseline more quickly. Serum sodium increased more rapidly in the over 60 as opposed to the under 30-ml/min group, but overall maximum increases were similar across groups. Small decreases in mean CrCL and small increases in mean serum creatinine/potassium were independent of baseline CrCL. The percent fractional free water clearance with respect to CrCL was significantly but negatively correlated with increasing baseline CrCL. No unexpected adverse events were reported. Thus, renal impairment attenuated the increase in 24-h urine volume and free water clearance caused by tolvaptan, consistent with decreased nephron function in renal impairment. The delay in serum sodium increase was consistent with the longer duration needed to excrete sufficient water to cause the increase.
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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.