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The Role Of FGF23, Klotho, And Sclerostin In Kidney Stone Formers

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. Identifier: NCT01526304
Recruitment Status : Unknown
Verified January 2012 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : February 3, 2012
Last Update Posted : February 3, 2012
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Kidney stones are very common in industrialized countries and the lifetime risk is about 10 to 15% in this population. Kidney stones are composed of inorganic and organic components. Calcium containing stones are the most common stone type accounting for more than 80% of kidney stones. Many factors predispose or contribute to the development of kidney stones, including genetic variants or mutations, diet, environmental factors, and behavior. To date, little is known on fibroblast growth factor (FGF23) levels in patients with calcium nephrolithiasis. FGF23 is crucial for phosphate homeostasis including physiological and pathophysiological conditions such as X-linked hypophosphatemic rickets and it seems that FGF23 is probably the most important regulator of serum phosphate and calcitriol (1,25(OH)2D3) levels in addition to parathyroid hormone (PTH) produced by the parathyroid gland. Novel factors such as Klotho and Sclerostin, which are involved in the bone-kidney-parathyroid endocrine axis, have been identified recently. Klotho is a putative aging suppressor gene and its deficiency results in osteopenia, hyperphosphaturia, and calcification. Klotho is mainly expressed in the kidney but also in the parathyroid gland and acts as a FGF23 specific co-receptor mediating FGF23 participation in the bone-kidney-parathyroid endocrine axis as described above. Sclerostin is a protein secreted by osteocytes that inhibits bone formation by osteoblasts. However, the potential role of FGF23, Klotho, and Sclerostin in nephrolithiasis is still poorly under-stood or even unexplored. The aim of this study is to test if levels of FGF23, Klotho, and Sclerostin are differentially regulated in kidney stone formers.

Condition or disease Intervention/treatment
Kidney Stones Other: no intervention

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cross-Sectional Study To Investigate The Role Of FGF23, Klotho, And Sclerostin In Kidney Stone Formers
Study Start Date : January 2012
Estimated Study Completion Date : January 2014

Intervention Details:
  • Other: no intervention
    No intervention, only observational study

Biospecimen Retention:   Samples Without DNA
Whole Blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All stoneformer patients at the first outpatient stone clinic consultation

Inclusion criteria:

- stoneformer patients with signed informed consent

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 identifier (NCT number): NCT01526304

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Contact: Marian Struker, Study Coordinator +41 (0)44 255 35 45
Contact: Nilufar Mohebbi, MD

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University Hospital Zurich, Nephrology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Nilufar Mohebbi, MD University Hospital Zurich, Division of Nephrology
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Responsible Party: University of Zurich Identifier: NCT01526304    
Other Study ID Numbers: SFS
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Kidney Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi