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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Meir Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Benaya Rozen-Zvi, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01423045
First received: August 23, 2011
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

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
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association Between Urine Concentration Ability and the Progression of Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • eGFR slope [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: August 23, 2011
Last Updated: August 24, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Chronic kidney disease
Urine osmolarity
Glomerular filtration rate

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

ClinicalTrials.gov processed this record on July 24, 2014