NCT02124395

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

8.9 years

First QC Date

April 23, 2014

Last Update Submit

August 31, 2022

Conditions

Primary HyperoxaluriaCystinuriaAdenine Phosphoribosyl Transferase DeficiencyDent Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Primary Hyperoxaluria

All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)

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

Cystinuria

All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)

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

Dent Disease

All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)

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

APRT deficiency

All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)

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

Interventions

Health-related Quality of Life in Rare Kidney Stone QuestionnaireOTHER
APRT deficiencyCystinuriaDent DiseasePrimary Hyperoxaluria

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sample will be selected from the Rare Kidney Stone Consortium registries

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Primary Hyperoxaluria and Dent Disease Registry - Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York University School of Medicine - Cystinuria Registry

New York, New York, 1001+, United States

Location

APRT Registry - Landspitali Universtiy Hospital

Reykjavik, Iceland

Location

Related 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.

    PMID: 24253538BACKGROUND

MeSH Terms

Conditions

Hyperoxaluria, PrimaryCystinuriaAdenine phosphoribosyltransferase deficiencyDent Disease

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

HyperoxaluriaKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesRenal AminoaciduriasRenal Tubular Transport, Inborn ErrorsGenetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • David Goldfarb, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 28, 2014

Study Start

August 1, 2013

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

September 2, 2022

Record last verified: 2022-08

Locations

IC(1)US(2)