ESRDKINDREDNCT03321604
Kidney Information Network for Disease Research and Education
An observational study of ESRD and Fabry Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this study, Investigators will conduct a prospective cohort study of dialysis patients by collecting research-quality information on patient characteristics, comorbid diseases and laboratory markers used in routine practice, as well as novel biochemical markers and genetic data. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ESRD, Fabry Disease, Rare Diseases
- How many people
- 338 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 21 Nov 2019
- How long will I take part?
- 1 Day
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults receiving dialysis
Who may be able to join
- Adults between 18 and 65 with ESRD undergoing dialysis.
Who cannot join
- Kidney biopsy unlikely to be Fabry disease; those with a diagnosis that is clinically or biochemically proven not to be Fabry disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02214
About this study
Official title: Kidney Information Network for Disease Research and Education (KINDRED)
In this study, Investigators will conduct a prospective cohort study of dialysis patients by collecting research-quality information on patient characteristics, comorbid diseases and laboratory markers used in routine practice, as well as novel biochemical markers and genetic data. Investigators will utilize data from the cohort to test the independent relationship between biochemical and genetic markers and Fabry disease and other rare diseases.
Read the detailed description
KINDRED is a prospective observational cohort study that will enroll up to 5,000 dialysis patients throughout the United States with and without known diagnosis of Fabry disease but at risk for Fabry disease (e.g., unknown cause of renal disease, young male, initiating dialysis without a kidney biopsy, etc).This tissue repository will allow for genetic screening of a geographically diverse population, assist in identification of rare diseases in ESRD, and collect research-quality information on risk factors and outcomes from an ethnically heterogeneous population of dialysis patients. In this study, Investigators will use a novel method of performing research in this population by leveraging the internet to enhance and accelerate recruitment of potential subjects to participate in a genetic screening/tissue repository protocol.
- Conditions
- ESRD, Fabry Disease, Rare Diseases, Kidney Diseases, End Stage Renal Disease, Genetic Diseases, X-Linked
- Keywords
- Hemodialysis, Kidney, Dialysis, Kindred, Fabry, Massachusetts General Hospital
- Medical subject headings
- Kidney Failure, Chronic, Fabry Disease, Rare Diseases, Kidney Diseases, Genetic Diseases, X-Linked
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetically determined Fabry disease prevalence amongst a heterogenous patient population with end-stage renal disease on dialysis in the US not previously known to have Fabry disease.
Measured: 5 years
Secondary outcomes (2)
Differences in patient characteristics of dialysis patients diagnosed with Fabry disease vs. dialysis patients who do not have Fabry disease.
Measured: 5 years
Differences in patient characteristics of individuals diagnosed with Fabry disease initiating dialysis after 2013 vs. patients with Fabry disease who started dialysis before 2003.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Jan 2018
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 338 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Scott and White Hospital & Clinic
- Responsible party
- Principal investigator, Ravi Thadhani, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321604
- Sponsor's protocol ID
- 2016P002671
- Acronym
- KINDRED
- Status last verified
- Feb 2021
- First submitted
- 23 Oct 2017
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Information Network for Disease Research and Education (KINDRED)
- ClinicalTrials.gov ID
- NCT03321604
- Acronym / sponsor ID
- KINDRED / 2016P002671
- Conditions
- ESRD, Fabry Disease, Rare Diseases, Kidney Diseases, End Stage Renal Disease, Genetic Diseases, X-Linked
- Keywords
- Hemodialysis, Kidney, Dialysis, Kindred, Fabry, Massachusetts General Hospital
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Scott and White Hospital & Clinic
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 25 Oct 2017 (actual)
- 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.
In this study, Investigators will conduct a prospective cohort study of dialysis patients by collecting research-quality information on patient characteristics, comorbid diseases and laboratory markers used in routine practice, as well as novel biochemical markers and genetic data. Investigators will utilize data from the cohort to test the independent relationship between biochemical and genetic markers and Fabry disease and other rare diseases.
Detailed description
KINDRED is a prospective observational cohort study that will enroll up to 5,000 dialysis patients throughout the United States with and without known diagnosis of Fabry disease but at risk for Fabry disease (e.g., unknown cause of renal disease, young male, initiating dialysis without a kidney biopsy, etc).This tissue repository will allow for genetic screening of a geographically diverse population, assist in identification of rare diseases in ESRD, and collect research-quality information on risk factors and outcomes from an ethnically heterogeneous population of dialysis patients. In this study, Investigators will use a novel method of performing research in this population by leveraging the internet to enhance and accelerate recruitment of potential subjects to participate in a genetic screening/tissue repository protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults receiving dialysis
Key inclusion criteria (1 listed)
- Adults between 18 and 65 with ESRD undergoing dialysis.
Key exclusion criteria (1 listed)
- Kidney biopsy unlikely to be Fabry disease; those with a diagnosis that is clinically or biochemically proven not to be Fabry disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetically determined Fabry disease prevalence amongst a heterogenous patient population with end-stage renal disease on dialysis in the US not previously known to have Fabry disease.
Time frame: 5 years
2 secondary outcomes
Differences in patient characteristics of dialysis patients diagnosed with Fabry disease vs. dialysis patients who do not have Fabry disease.
Time frame: 5 years
Differences in patient characteristics of individuals diagnosed with Fabry disease initiating dialysis after 2013 vs. patients with Fabry disease who started dialysis before 2003.
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- KINDRED WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ESRD and Fabry Disease, run by Massachusetts General Hospital at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Poor recruitment). Results are not available in the source record.
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?
Genetically determined Fabry disease prevalence amongst a heterogenous patient population with end-stage renal disease on dialysis in the US not previously known to have Fabry disease. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2021.