Efficacy Study of Water Drinking on PKD Progression. - Full Text View

Sponsor:	Kyorin University
Information provided by (Responsible Party):	Eiji Higashihara, MD, Kyorin University
ClinicalTrials.gov Identifier:	NCT01348035

Purpose

Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disease. Numerable cysts develop in renal tubule cells, which cause progressive renal enlargement and functional deterioration in ADPKD. Tubule cells proliferation is stimulated by 3'-5'-cyclic adenosine monophosphate (cAMP). Arginine vasopressin (AVP) operates through stimulation of cAMP, hence contributing renal enlargement in ADPKD patients. Studies in animal models of ADPKD provide convincing evidence that antagonizing AVP action results in inhibition of disease progression. It is postulated that large water intake in patients with ADPKD will decrease plasma AVP concentration and mitigate the action of cAMP on the renal tubule resulting in the amelioration of disease progression. However the effects of long-standing water intake on plasma AVP level and cyst development in ADPKD patients are not known. Therefore, long-term (12 months) efficacy study of water diuresis induced by oral water intake on kidney volume and renal function in ADPKD patients are designed.

Condition
Autosomal Dominant Polycystic Kidney Disease. Disease Progression

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Efficacy Study of Long-term Water Intake on the Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Further study details as provided by Kyorin University:

Primary Outcome Measures:

Total Kidney Volume (TKV) measured by MRI. [ Time Frame: One year (12 months) ] [ Designated as safety issue: No ]
The relationship between urine volume (and urine osmolality) and change of TKV.

Secondary Outcome Measures:

GFR estimated by plasma creatinine and cystatin C. [ Time Frame: One year (12 months) ] [ Designated as safety issue: No ]
The relationship between urine volume (and urine osmolality) and change of GFR.
Plasma AVP (Copeptine) level. [ Time Frame: 4-8-12 months ] [ Designated as safety issue: No ]
The relationship between urine volume (osmolality) and plasma AVP.
QOL questionnaire. [ Time Frame: 4-8-12 months ] [ Designated as safety issue: No ]
The relationship between QOL and urine volume.

Biospecimen Retention: Samples Without DNA

Urine

Estimated Enrollment:	30
Study Start Date:	April 2011
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Water Load Group Water load group: 2.5 ~ 3 L water intake daily for 12 months (50ml/Kg BW/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.

Detailed Description:

Half of the consented patients (n=15) are encouraged to take large amount of water (2.5 ~ 3 L water intake daily for 12 months. 50ml/Kg BW/day). However when large amount water intake is not sustainable, patients can reduce the amount of water intake to the levels as much as large they can sustain.

Another half of the patients (n=15) are free to access water, according to their own habitual manner.

The urine volume and osmolality are expected to distribute relatively wide range. Analysis of the effects of water intake on TKV and GFR is expected to be possible.

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The patients who visit Kyorin University Hospital.

Criteria

Inclusion Criteria:

The patients with ADPKD
The patients who consent to the study protocol
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 SSRI (Selective serotonin reuptake inhibitors), tricyclic antidepressants or diuretics.
The patients who is considered inappropriate by physicians.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348035

Contacts

Contact: Eiji Higashihara, M.D.	+81-422-47-5511 ext 5813	ehigashi@ks.kyorin-u.ac.jp
Contact: Kikuo Nutahara, M.D.	+81-422-47-5511 ext 7445	kinuta@ks.kyorin-u.ac.jp

Locations

Japan
Department of Urology, Kyorin University Hospital	Recruiting
Mitaka, Tokyo, Japan, 181-8611
Contact: Eiji Higashihara, M.D. +81-422-47-5511 ext 5813 ehigashi@ks.kyorin-u.ac.jp
Contact: Kikuo Nutahara, M.D. +81-422-47-5511 ext 7445 kinuta@ks.kyorin-u.ac.jp
Principal Investigator: Eiji Higashihara, M.D.
Sub-Investigator: Kikuo Nutahara, M.D.
Sub-Investigator: Takatsugu Okegawa, M.D.
Sub-Investigator: Mitsuhiro Tanbo, M.D.
Sub-Investigator: Toshiaki Nitadori, M.D.
Sub-Investigator: Kuninori Kobayashi, Radiol Tech

Sponsors and Collaborators

Kyorin University

Investigators

Principal Investigator:

Eiji Higashihara, M.D.

Kyorin University

More Information

No publications provided

Responsible Party:	Eiji Higashihara, MD, Professor, Kyorin University
ClinicalTrials.gov Identifier:	NCT01348035 History of Changes
Other Study ID Numbers:	KYR-003-PKD
Study First Received:	May 3, 2011
Last Updated:	May 1, 2012
Health Authority:	Japan: Institutional Review Board

Keywords provided by Kyorin University:

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

Additional relevant MeSH terms:

Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Disease Progression

Urologic Diseases
Kidney Diseases, Cystic
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012