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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01526304
First received: January 31, 2012
Last updated: February 2, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Kidney Stones
Other: no intervention
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Biospecimen Retention:   Samples Without DNA

Whole Blood


Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Intervention Details:
    Other: no intervention
    No intervention, only observational study
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All stoneformer patients at the first outpatient stone clinic consultation

Criteria

Inclusion criteria:

- stoneformer patients with signed informed consent

  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: NCT01526304

Contacts
Contact: Marian Struker, Study Coordinator +41 (0)44 255 35 45 marian.struker@usz.ch
Contact: Nilufar Mohebbi, MD nilufar.mohebbi@usz.ch

Locations
Switzerland
University Hospital Zurich, Nephrology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Nilufar Mohebbi, MD University Hospital Zurich, Division of Nephrology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01526304     History of Changes
Other Study ID Numbers: SFS
Study First Received: January 31, 2012
Last Updated: February 2, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Calculi
Kidney Diseases
Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014