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Association Between Urine Concentration Ability and the Progression of Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01423045
Recruitment Status : Unknown
Verified August 2011 by Benaya Rozen-Zvi, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 25, 2011
Last Update Posted : August 25, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The study hypothesis is that urine concentrating ability can predict the rate of kidney function decline.

Patients with kidney disease at the investigatorsclinic will be asked to give first morning urine sample and osmolarity will be measured. The investigators will follow up kidney function decline and check if there is association with urine osmolarity.


Condition or disease
Chronic Kidney Disease

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association Between Urine Concentration Ability and the Progression of Chronic Kidney Disease
Study Start Date : October 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. eGFR slope [ Time Frame: 12 month ]
    Creatinnie value will be measured at least every three month and eGFR will be calculated by MDRD equation. A regression line will be plotted against time and the eGFR slope will be calculated.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with CKD and estimated GFR of less then 50 mL per minute.
Criteria

Inclusion Criteria:

  • Patients with CKD and estimated GFR of less then 50 mL per minute estimated by the short MDRD equation base on two creatinine values taken at least two weeks apart and are not getting steroids or immunosuppressive medication as treatment for their primary kidney disease.

Exclusion Criteria:

  1. Life expectancy of less then 6 month.
  2. Expected to start renal replacement therapy within 3 month.
  3. Acute or acute on chronic renal failure with reversible component.
  4. Treatment with AVP inhibitors.
  5. Chronic hyponatremia (Na+<135 in two measurement two weeks apart).
  6. Primary polydipsia.
  7. Inability to give informed consent.
  8. Clinical hypovolemia.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423045


Locations
Israel
Pre dialysis clinic Dan Petach Tiqua county General health service Not yet recruiting
Ganey Tiqua, Israel, 55900
Contact: Benaya Rozen-zvi, MD    050-8773766    benayarz@gmail.com   
Contact: Boris Zingerman, MD    050-6260428    borisz@clalit.org.il   
Sponsors and Collaborators
Benaya Rozen-Zvi
Investigators
Principal Investigator: Benaya Rozen-Zvi, MD General health services - Dan Petach tiqua county
More Information

Responsible Party: Benaya Rozen-Zvi, attending nephrologist pre dialysis clinic Dan petach-tiqua county, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01423045     History of Changes
Other Study ID Numbers: UCONC
First Posted: August 25, 2011    Key Record Dates
Last Update Posted: August 25, 2011
Last Verified: August 2011

Keywords provided by Benaya Rozen-Zvi, Meir Medical Center:
Chronic kidney disease
Urine osmolarity
Glomerular filtration rate

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency