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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium
- ClinicalTrials.gov ID
- NCT02124395
- Acronym / sponsor ID
- 13-00968
- Conditions
- Primary Hyperoxaluria, Cystinuria, Adenine Phosphoribosyl Transferase Deficiency, Dent Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2013 (actual)
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary Hyperoxaluria | – | Other: Health-related Quality of Life in Rare Kidney Stone QuestionnaireAll 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) |
| Cystinuria | – | Other: Health-related Quality of Life in Rare Kidney Stone QuestionnaireAll 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) |
| Dent Disease | – | Other: Health-related Quality of Life in Rare Kidney Stone QuestionnaireAll 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) |
| APRT deficiency | – | Other: Health-related Quality of Life in Rare Kidney Stone QuestionnaireAll 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) |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sample will be selected from the Rare Kidney Stone Consortium registries
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None, if inclusion criteria are met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health-related Quality of Life in Rare Kidney Stone Questionnaire | Other | APRT deficiency, Cystinuria, Dent Disease, Primary Hyperoxaluria |
Primary outcome
Assessment of HRQoL in patients with rare kidney stones
Time frame: Once a year for up to 5 years after signed consent
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 24253538Modersitzki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Goldfarb, MD principal investigator
NYU Langone Health
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperoxaluria and Cystinuria, run by NYU Langone Health at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of HRQoL in patients with rare kidney stones (time frame: Once a year for up to 5 years after signed consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02124395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.