Swiss Kidney Stone Cohort (SKSC)

Kidney Stone Clinical Trial

— SKSC  

Official title:

Swiss Kidney Stone Cohort (SKSC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01990027
• Other study ID #: KEK-2013-0330
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2013
• Last updated: November 28, 2017
• Start date: April 2014
• Est. completion date: April 2024

Study information

• Verified date: November 2017
• Source: The Swiss National Centre of Competence in Research Kidney Control of Homeostasis
• Contact: Olivier Bonny, MD-PhD
• Email: Olivier.Bonny[@]unil.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The SKSC is a continuous database with the objective of a standardized diagnosis and monitoring of patients with kidney stones as well as the establishment of a Biobank.

Description:

The objective of this study is multi-site, standardized observation and characterization of kidney stone patients.

Furthermore, an adequate structure should be established for the execution of studies with kidney stone patients, in order to then, if necessary, develop recommendations for useful monitoring or prophylactic measures, as well as new treatment options for kidney stone patients.

A control group of 250 stone-free volunteers matching patients cohort participants for sex and age started recruitment in October 2017 and will serve the purpose of comparison in future studies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For SKSC Patients Group:

Inclusion Criteria:

Only patients that meet all of the following inclusion criteria can be included in this study:

• Signed Declaration of informed consent

• Male or female

• Recurrent kidney stone episodes (more than 1) or an individual kidney stone episode with one or several of the following risk factors:

• The first manifestation at the a minimum age of 25

• Positive family history

• Non-calcium oxalate stones

• Gastrointestinal disorders (e.g. gastric bypass surgery, inflammatory bowel disease, malabsorption etc.)

• Osteoporosis

• Nephrocalcinosis

• Single kidneyness

• Currently pregnant

• Gout

• Metabolic syndrome ( Diabetes Mellitus type I and II )

• Residual calculi (at least 3 months after the therapy)

• Bilateral or multiple stones

• Chronic urinary tract infection

• Chronic renal failure (eGFR lower than 60 ml/min.)

• Kidney transplant

Exclusion Criteria:

Patients with at least one of the following exclusion criteria may not take part in this study.

• Not signed Informed Consent form

• Age below 18 years old

For SKSC Control Group

Inclusion criteria:

• Signed Declaration of informed consent

• Male or female

• Kidney-stone free (screening verification by low-dose CT-scan)

Exclusion criteria:

• Not signed Informed Consent form

• Age below 18 years old

• Pregnancy

• History of kidney stones

• Low-dose CT-scan positive for kidney stones during screening phase

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau	Kanton Aargau
Switzerland	Universitätsspital Basel	Basel
Switzerland	Inselspital	Bern
Switzerland	HUG	Geneva	GE
Switzerland	CHUV	Lausanne
Switzerland	USZ	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
The Swiss National Centre of Competence in Research Kidney Control of Homeostasis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiological characterization	Epidemiological characterization of kidney stone patients	10 years

External Links

•   Link