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NCT02124395 Clinical Trial

Health-related Quality of Life in Rare Kidney Stone

Primary Hyperoxaluria Clinical Trial

Official title:
Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02124395
Other study ID # 13-00968
Secondary ID 1U54DK083908-01
Status Completed
Phase
First received
Last updated
Start date August 2013
Est. completion date July 2022

Study information
Verified date August 2022
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium

Description:

The purpose of this study is to learn about Health-related Quality Of Life (HRQoL) in patients enrolled in the Rare Kidney Stone Consortium (RKSC) registries. Quality of life studies look at different aspects of both physical and mental components of people's lives. HRQoL data for people affected by kidney stones are not currently available for people followed over time.

Recruitment information / eligibility
Status Completed
Enrollment 365
Est. completion date July 2022
Est. primary completion date July 2022
Accepts healthy volunteers No
Gender All
Age group 5 Years and older
Eligibility Inclusion Criteria: - Qualify to participate in one of the Rare Kidney Stone Registries. - Be at least 5 years old (for SF-10) - Are able to communicate using the English language - Consent to participate in the study (or "assent" if under 18 years old) - Have internet access with an email account or a valid home address Exclusion Criteria: None, if inclusion criteria are met

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Health-related Quality of Life in Rare Kidney Stone Questionnaire

Locations
Country Name City State
Iceland APRT Registry - Landspitali Universtiy Hospital Reykjavik
United States New York University School of Medicine - Cystinuria Registry New York New York
United States Primary Hyperoxaluria and Dent Disease Registry - Mayo Clinic Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
NYU Langone Health National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Iceland, 

References & Publications (1)

Modersitzki F, Pizzi L, Grasso M, Goldfarb DS. Health-related quality of life (HRQoL) in cystine compared with non-cystine stone formers. Urolithiasis. 2014 Feb;42(1):53-60. doi: 10.1007/s00240-013-0621-4. Epub 2013 Nov 20. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of HRQoL in patients with rare kidney stones Assessment of HRQoL in patients with rare kidney stones. Comparison of HRQoL results between rare kidney stone formers, general population and other populations with relevant chronic diseases Once a year for up to 5 years after signed consent
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