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Factors Related to the Progression of Chronic Kidney Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Ankara Education and Research Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01317173
First Posted: March 17, 2011
Last Update Posted: March 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ankara Education and Research Hospital
  Purpose
Chronic kidney disease is a progressive disorder that has been influenced with many factors. Most of the patients has altered Ca P metabolism and these dis orders are the contributing factors of the disease progression. It has been recently documented that FGF23 and Klotho are the key factors of PTH secretion Ca-P metabolism. This study aimed to evaluate the impact of Klotho and FGF23 on the progression of stage 3-4 chronic kidney disease.

Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of FGF23 and Klotho on Progression of Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Ankara Education and Research Hospital:

Primary Outcome Measures:
  • Progression of kidney disease [ Time Frame: continuous measurement of kidney functions 3 monthly for two years or until the outcome reached ]
    Doubling of creatinin, requirement of renal replacement therapy


Secondary Outcome Measures:
  • Evaluation of Ca P metabolism [ Time Frame: 3 monthly for two years or until the outcome reached ]
    Determination of Ca-P metabolism disorders.


Estimated Enrollment: 90
Study Start Date: March 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Progressive disease
Serum creatinin level rise more than 2 times
Non-progressive disease
Serum creatinin level rise less than 2 times

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with non-diabetic chronic kidney disease between the ages of 18 and 65 years old.
Criteria

Inclusion Criteria:

  • Non-diabetic chronic kidney disease

Exclusion Criteria:

  • Presence of DM
  • Actively using calcium based phosphorus binder of vitamin D
  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): NCT01317173


Locations
Turkey
Ankara Education and Research Hospital
Ankara, Turkey
Sponsors and Collaborators
Ankara Education and Research Hospital
  More Information

Responsible Party: Alper AZAK, Ankara Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01317173     History of Changes
Other Study ID Numbers: NEPH001
First Submitted: March 16, 2011
First Posted: March 17, 2011
Last Update Posted: March 17, 2011
Last Verified: January 2011

Keywords provided by Ankara Education and Research Hospital:
Chronic kidney disease progression
FGF 23
Klotho

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Disease Progression
Urologic Diseases
Renal Insufficiency
Disease Attributes
Pathologic Processes