Primary HyperoxaluriaNCT02124395
Health-related Quality of Life in Rare Kidney Stone
An observational study of Primary Hyperoxaluria and Cystinuria, run by NYU Langone Health at 3 sites in 2 countries.
Trial summary
Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Primary Hyperoxaluria, Cystinuria, Adenine Phosphoribosyl Transferase Deficiency
- What is being tested?
- Health-related Quality of Life in Rare Kidney Stone Questionnaire
- How many people
- 365 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2013to Jul 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sample will be selected from the Rare Kidney Stone Consortium registries
Who may be able to join
- 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
Who cannot join
- None, if inclusion criteria are met
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
New York University School of Medicine - Cystinuria Registry
New York, New York, 1001+
Primary Hyperoxaluria and Dent Disease Registry - Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium
Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium
Read the detailed 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.
- Conditions
- Primary Hyperoxaluria, Cystinuria, Adenine Phosphoribosyl Transferase Deficiency, Dent Disease
- Being tested
- Health-related Quality of Life in Rare Kidney Stone Questionnaire
- Medical subject headings
- Hyperoxaluria, Primary, Cystinuria, Adenine phosphoribosyltransferase deficiency, Dent Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-related Quality of Life in Rare Kidney Stone QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Once a year for up to 5 years after signed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startAug 2013
- Primary completionJul 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HyperoxaluriaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 365 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Goldfarb, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124395
- Sponsor's protocol ID
- 13-00968
- Other IDs
- 1U54DK083908-01
- Status last verified
- Aug 2022
- First submitted
- 23 Apr 2014
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24253538