CystinosisNCT00004312
Establishment of a Database for Long-Term Monitoring of Patients With Nephropathic Cystinosis
An observational study of Cystinosis, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
OBJECTIVES: I. Establish a computerized databank to monitor the progress of patients with cystinosis treated with cysteamine. II. Track and monitor all patients including renal transplant, dialysis and post renal transplants. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Cystinosis
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to not given
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
Nephropathic cystinosis diagnosis by white-cell cystine measurement, including infantile and late-onset forms
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego School of Medicine
La Jolla, California, 92093-0652
About this study
OBJECTIVES: I. Establish a computerized databank to monitor the progress of patients with cystinosis treated with cysteamine.
II. Track and monitor all patients including renal transplant, dialysis and post renal transplants.
Read the detailed description
PROTOCOL OUTLINE:
Data are collected from patients and physicians. Information includes disease, treatment, family history, demographic, and physical exam data. The dates of kidney transplantation and/or dialysis initiation are also recorded.
- Conditions
- Cystinosis
- Keywords
- cystinosis, rare disease, renal and genitourinary disorders
- Medical subject headings
- Cystinosis, Rare Diseases, Urogenital Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startOct 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystinosisStudies of the same condition, open and under way.
- 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
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, San Diego
- Investigators
- Jerry A. Schneider, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004312
- Sponsor's protocol ID
- NCRR-M01RR00827-1196
- Other IDs
- UCSD-970026, UCSD-950338
- Status last verified
- Dec 2003
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Database for Long-Term Monitoring of Patients With Nephropathic Cystinosis
- ClinicalTrials.gov ID
- NCT00004312
- Acronym / sponsor ID
- NCRR-M01RR00827-1196
- Conditions
- Cystinosis
- Keywords
- cystinosis, rare disease, renal and genitourinary disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, San Diego
- Study start
- Oct 1999
- First posted
- 19 Oct 1999 (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.
OBJECTIVES: I. Establish a computerized databank to monitor the progress of patients with cystinosis treated with cysteamine.
II. Track and monitor all patients including renal transplant, dialysis and post renal transplants.
Detailed description
PROTOCOL OUTLINE:
Data are collected from patients and physicians. Information includes disease, treatment, family history, demographic, and physical exam data. The dates of kidney transplantation and/or dialysis initiation are also recorded.
Study design
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 24 Jun 2005.
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DFT383 in Pediatric Participants With Nephropathic Cystinosis
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Pilot Study of TTI-0102 in Cystinosis
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RecruitingObservational study
Use of Cysteamine in the Treatment of Cystinosis
Cystinosis
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.
Jerry A. Schneider study chair
University of California, San Diego
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 Cystinosis, run by National Center for Research Resources (NCRR) 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?
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 24 Jun 2005. 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 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.
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 Jun 2005.