NCT01423045

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

August 25, 2011

Status Verified

August 1, 2011

Enrollment Period

2 years

First QC Date

August 23, 2011

Last Update Submit

August 24, 2011

Conditions

Keywords

Chronic kidney diseaseUrine osmolarityGlomerular filtration rate

Outcome Measures

Primary Outcomes (1)

  • eGFR slope

    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.

    12 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with CKD and estimated GFR of less then 50 mL per minute.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pre dialysis clinic Dan Petach Tiqua county General health service

Ganey Tiqua, 55900, Israel

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Benaya Rozen-Zvi, MD

    General health services - Dan Petach tiqua county

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
attending nephrologist pre dialysis clinic Dan petach-tiqua county

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 25, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

August 25, 2011

Record last verified: 2011-08

Locations