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The NOCTURNE Randomized Trial Comparing 2 Tolvaptan Formulations.

Ronald D Perrone1, Arlene B Chapman2, Dorothee Oberdhan3

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Kidney International Reports
|June 11, 2020
PubMed
Summary

Tolvaptan modified-release (MR) and immediate-release (IR) formulations showed similar short-term efficacy in reducing total kidney volume in autosomal dominant polycystic kidney disease (ADPKD) patients. Both formulations were generally well-tolerated with minimal impact on quality of life.

Keywords:
autosomal dominant polycystic kidney diseaseclinical trialpharmacodynamicspharmacotherapytolvaptan

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Area of Science:

  • Nephrology
  • Pharmacology
  • Clinical Trials

Background:

  • Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disorder characterized by kidney cyst formation.
  • Tolvaptan targets the vasopressin V2 receptor pathway, a key driver of cyst growth in ADPKD.
  • Aquaretic adverse events (AAEs) are a known side effect of tolvaptan treatment.

Purpose of the Study:

  • To compare the short-term efficacy and tolerability of a once-daily modified-release (MR) tolvaptan formulation against a twice-daily immediate-release (IR) formulation in ADPKD patients.
  • To evaluate the impact of different tolvaptan formulations on total kidney volume (TKV) and quality of life (QOL).

Main Methods:

  • Phase 2, multicenter, randomized, double-blind, placebo-controlled study (NCT01451827) involving 177 ADPKD subjects.
  • Comparison of tolvaptan MR (50 mg or 80 mg once daily) and tolvaptan IR (60/30 mg daily split dose) against placebo over 8 weeks.
  • Primary endpoint: percent change in TKV at week 3. Secondary endpoints included tolerability and QOL measures.

Main Results:

  • Tolvaptan MR (50 mg and 80 mg) and the pooled tolvaptan group demonstrated statistically significant reductions in TKV at week 3 compared to placebo (P < 0.02).
  • Tolvaptan IR did not show a significant decrease in TKV at week 3 (P = 0.24).
  • All tolvaptan regimens were associated with AAEs, but patient-reported outcomes indicated minimal impact on overall health-related QOL.

Conclusions:

  • Both tolvaptan MR and IR formulations exhibited comparable short-term efficacy and tolerability in ADPKD patients.
  • The tested tolvaptan regimens had a low impact on multiple QOL measures.
  • Long-term efficacy conclusions are limited due to the study's short follow-up duration.