Efficacy Study of Water Drinking on PKD Progression.

NCT01348035 | Completed

• 1 other identifier: KYR-003-PKD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease; Disease Progression

Keywords

Autosomal Dominant Polycystic Kidney Disease.; Arginine vasopressin; Total Kidney Volume; Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (3)

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

  One year (12 months)

• Plasma arginine vasopressin (AVP, Copeptin) level.

  4-8-12 months

• Quality of life (QOL) questionnaire.

  4-8-12 months

Study Arms (2)

Water Load Group

Water load group: 2.5 \~ 3 L water intake daily for 12 months (50ml/Kg body weight/day). When large amount water intake is not sustainable, patients can reduce the amount of water intake to the levels as much as large he or she can sustain.

Non-Water Loaded Group

Non-water load group: The patients are free to access water intake, as they like.

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients who visit Kyorin University Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyorin University: lead

Study Sites (1)

Department of Urology, Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Disease Progression; Diabetes Insipidus

Condition Hierarchy (Ancestors)

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

Study Officials

• Eiji Higashihara, M.D.

  Kyorin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 5, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)