NCT02378805 Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport Syndrome
| NCT ID | NCT02378805 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Goettingen |
| Condition | Alport Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 1995-07 |
| Primary Completion | 2036-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 1995-07 with a primary completion date of 2036-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The hereditary type IV collagen disease Alport syndrome leads to kidney failure early in life. Currently there are no specific medications approved for treatment, however, several therapies have been evaluated preclinically and could improve outcome. For that reason, this non-interventional, observational study investigates, if medications (1) delay disease progression; (2) delay time to kidney failure; (3) improve life-expectancy compared to untreated patients (relatives). This observational study started in 2006 as an European registry. Since 2019, this registry has been expanded to "Alport XXL" via the International Alport Alliance as a global effort across all continents. From 2020 on to present, "Alport XXL" has a special focus on the outcomes of early therapy in young patients on ACE-inhibitors vs. Angiotensin-receptor blockers vs. their combination.
Eligibility Criteria
Inclusion Criteria: Diagnosis of Alport syndrome (AS) by kidney biopsy or mutation analysis (or both). Any type of genetic variant is accepted for X-linked, autosomal or digenic Alport syndrome (COL4A3, 4 or 5 genes). Exclusion criteria: Patients not willing to give informed consent. Patient with suspected diagnosis, whcih cannot be confirmed.
Contact & Investigator
Oliver Gross, MD
PRINCIPAL INVESTIGATOR
University Hospital Goettingen
Frequently Asked Questions
Who can join the NCT02378805 clinical trial?
This trial is open to participants of all sexes, studying Alport Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02378805 currently recruiting?
Yes, NCT02378805 is actively recruiting participants. Contact the research team at gross.oliver@med.uni-goettingen.de for enrollment information.
Where is the NCT02378805 trial being conducted?
This trial is being conducted at Göttingen, Germany.
Who is sponsoring the NCT02378805 clinical trial?
NCT02378805 is sponsored by University Hospital Goettingen. The principal investigator is Oliver Gross, MD at University Hospital Goettingen. The trial plans to enroll 800 participants.