ArticleKidney international reports2020
A Randomized Trial of Modified-Release Versus Immediate-Release Tolvaptan in ADPKD.
Article in Kidney international reports, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01210560 (A Multi-center, Parallel-group, Randomized, Double-blind, Placebo-masked, Multiple Dose Trial of Modified-release), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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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.
A Multi-center, Parallel-group, Randomized, Double-blind, Placebo-masked, Multiple Dose Trial of Modified-release (MR) and Immediate-release (IR) Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.
- Interventions for preventing the progression of autosomal dominant polycystic kidney disease.The Cochrane database of systematic reviews · 2024Pooled it
- The PKD Daily: Development and Content Validation of a Hybrid Diary for Tracking Urinary Events in Adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD).Advances in therapy · 2026Article
- Identifying the main predictors of urine output in autosomal-dominant polycystic kidney disease (ADPKD) patients taking tolvaptan.International urology and nephrology · 2023Article
- Interaction Between Determinants Governing Urine Volume in Patients With ADPKD on Tolvaptan and its Impact on Quality of Life.Kidney international reports · 2023Article
- Dietary Aspects and Drug-Related Side Effects in Autosomal Dominant Polycystic Kidney Disease Progression.Nutrients · 2022Review
- The NOCTURNE Randomized Trial Comparing 2 Tolvaptan Formulations.Kidney international reports · 2020Article
- No Change in Nocturia After NOCTURNE.Kidney international reports · 2020Article
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Authors and funding
7 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTolvaptan, for treatment of autosomal dominant polycystic kidney disease (ADPKD), is provided as immediate-release (IR) tablets administered twice daily in split-dose regimens to suppress urine osmolality to <300 mOsm/kg. A modified-release (MR) formulation was developed for once-daily (QD) dosing to increase compliance and mitigate urinary symptom burden. This phase 2, dose-ranging study (NCT01210560) compared pharmacokinetics, pharmacodynamics, and tolerability of several MR regimens with IR in patients with ADPKD.
methodsThis was a multicenter, parallel-arm, randomized, crossover, double-blind, placebo-controlled trial. Each of 2 study arms had 12 subjects and 3 crossover periods. Dose regimens were administered for 7 days; placebo-masked QD versus split-dose treatments. Endpoints included pharmacokinetic parameters, percentage of subjects with urine osmolality <300 mOsm/kg, urine volume, number of daily urine voids, and tolerability.
resultsTolvaptan MR 20 to 120 mg exhibited dose-proportional pharmacokinetics. Percentage of subjects with spot urine osmolality <300 mOsm/kg increased with dose, with tolvaptan MR 120 mg and IR 90+30 mg each suppressing 91.7% of subjects below this level. Urinary burden on the ADPKD Nocturia Quality of Life, ADPKD Urinary Urgency, and ADPKD Urinary Frequency Questionnaires correlated with tolvaptan exposure, with high interindividual variability in responses. Changes in questionnaire scores were sensitive to changes in urine volume but not proportional to volume change, reflecting differences in subject tolerance to increased urine volume.
conclusionTolvaptan MR exhibited predictable and dose-proportional pharmacokinetics and no improvement in tolerability versus tolvaptan IR. Tolerability of the urinary effects of treatment within the high-dose MR and IR groups exhibited substantial interindividual variability.
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