European Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport Syndrome: Current and Novel Therapies

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
Germany
University Medical Center Göttingen
RECRUITING
Göttingen
Contact Information
Primary
Oliver Gross, MD
gross.oliver@med.uni-goettingen.de
+49-551-39-
Time Frame
Start Date: 1995-07
Estimated Completion Date: 2036-03-01
Participants
Target number of participants: 800
Treatments
no-T: untreated patients
untreated patients, typically uncles or grandfathers of present patients. No Intervention (means no therapy until CKD stage V, on renal replacement therapy)
T-III: late therapy in patients
patients treated with medications with low eGFR (below 60 ml/min) (starts at patients with CKD stages III and IV).
T-II: early therapy in patients
therapy starts in patients with albuminuria \>300mg/gCreatinine and eGFR higher than 60 ml/min.
T-I: very early therapy in patients
therapy starts in patients with microhematuria only (usually at birth) or microalbuminuria (30-300 mg albumin per gCreatinine).
no therapy in heterozygous patients
heterozygous patients without therapy
therapy in heterozygous patients
heterozygous patients with therapy (which also can be divided into subgroups stage T-0, I, II, III)
Related Therapeutic Areas
Sponsors
Leads: University Hospital Goettingen
Collaborators: Society for Pediatric Nephrology (Germany)

This content was sourced from clinicaltrials.gov