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Efficacy of Tolvaptan on ADPKD Patients

NCT02729662 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2020-06-05

No results posted yet for this study

Summary

Investigation of the therapeutic effects of tolvaptan in patients with autosomal dominant polycystic kidney disease This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 5 years (data cut-off, Aug 31, 2020).

Conditions

  • Autosomal Dominant Polycystic Kidney Disease

Interventions

DRUG

Tolvaptan

* Before administration of tolvaptan * TKV・Liver capacity: Once/year (an additional measurement within 3 months before start of administration) * 24-hour urine collection・Hematology/urinalysis: Once/year * Physical findings: Blood pressure and medical interview at ambulatory visit * Hospitalization for education and examination at the start of tolvaptan administration * 24-hour urine collection・Hematology/urinalysis・Inulin clearance * Physical findings: Body weight, blood pressure * Adverse Events * After administration of tolvaptan * TKV・Liver capacity・inulin clearance: Once/year * 24-hour urine collection: Once/6 months * Hematology/urinalysis: Once/month in principle * Physical findings: Blood pressure and medical interview at ambulatory visit * Adverse Events

Sponsors & Collaborators

  • Kyorin University

    lead OTHER

Principal Investigators

  • Eiji Higashihara, MD · Kyorin University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2020-08-31
Completion
2021-09-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02729662 on ClinicalTrials.gov