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Completed

NCT Number: NCT01348035

Efficacy Study of Water Drinking on PKD Progression.

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.

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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Insipidus Disease Attributes Disease Progression Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Urology, Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

About this study

Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in March 2014. 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 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients with ADPKD
  • The patients who consent to the study protocol
  • Estimated glomerular filtration rate (eGFR) or Creatinine Clearance greater than 50ml/min/1.73m2

Exclusion criteria

  • Patients who might be danger to drink large amount of water such as having heart failure or past history of cerebrovascular or cardiovascular disorders.
  • The patients who take habitual medication which affects the AVP action such as selective serotonin reuptake inhibitors (SSRI ), tricyclic antidepressants or diuretics.
  • The patients who is considered inappropriate by physicians.

Treatment and study plan

Primary outcomes

  1. Total kidney volume (TKV) measured by magnetic resonance imaging (MRI).

    Time frame: One year (12 months) and pre-study period.

    The relationship between urine volume (and urine osmolality) and change of TKV. TKV slopes are compared between pre-study and study period.

Secondary outcomes

  1. Glomerular filtration rate (GFR) estimated by plasma creatinine and cystatin C.

    Time frame: One year (12 months)

    The relationship between urine volume (and urine osmolality) and change of GFR.

  2. Plasma arginine vasopressin (AVP, Copeptin) level.

    Time frame: 4-8-12 months

    The relationship between urine volume (osmolality) and plasma AVP.

  3. Quality of life (QOL) questionnaire.

    Time frame: 4-8-12 months

    The relationship between QOL and urine volume.

Sponsors and collaborators

Lead sponsor

Kyorin University

Other

Registry information

Official study title

Efficacy Study of Long-term Water Intake on the Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Acronym: ESWP

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
May 5, 2011
Registry last updated
Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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