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Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport Syndrome

Study acronym: Alport-XXL
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Enrollment target: 500 to 800v9 Show 11 more changesShow less
    • Primary completion date: Jul 2010 to Mar 1, 2036
    • Primary endpoints: 2 to 4
    • Study completion date: Jan 2035 to Mar 1, 2036
    • Interventions: ACE-inhibitor (Drug), AT1-inhibitor (Drug), HMG-Coenzyme inhibitor (statin) (Drug), Paricalcitol (Drug), SGLT2 inhibitor (Drug)… to ACE-inhibitor (Drug), Angiotensin-receptor blocker (ARB) (Drug), HMG-Coenzyme inhibitor (statin) (Drug), Paricalcitol (Drug), SGLT2…
    • Eligibility criteria shortened, about 88 words
    • Secondary endpoints: 3 to 8
    • Study description expanded, about 210 words
    • Study site revised
    • Collaborators: 5 to 1
    • Publications: 9 to 11
    • Study title shortened, about 1 word
  2. Interventions: ACE-inhibitor (Drug), AT1-inhibitor (Drug), HMG-Coenzyme inhibitor (statin) (Drug), Paricalcitol (Drug), Spironolactone (Drug) to ACE-inhibitor (Drug), AT1-inhibitor (Drug), HMG-Coenzyme inhibitor (statin) (Drug), Paricalcitol (Drug), SGLT2 inhibitor (Drug)…
    • Publications: 6 to 9
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Study completion date: Jul 2020 to Jan 2035v6
  5. Study completion date: Jul 2019 to Jul 2020
    • Publications: 5 to 6
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Site contact updatedv4
  2. Publications: details revised at 1 of 5 entriesv3
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02378805
Lead Sponsor University Hospital Goettingen
Collaborators: Society for Pediatric Nephrology (Germany)
Conditions
(from sponsor)		 Alport Syndrome, Hereditary Kidney Disease, Pediatric Kidney Disease, Thin Basement Membrane Disease, Familial Benign Hematuria
Related terms Hematuria, Benign Familial, Nephritis, Hereditary
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov