Recruiting NCT01522183
Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atypical Hemolytic-Uremic Syndrome. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Canada, Denmark +12
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)
Overview
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
Detailed description
The study will capture post-marketing safety data on patients treated with eculizumab or ravulizumab. Additionally, the study will collect information on the progression of disease in all patients.
Primary outcome measures
- Proportion of patients who experience specified events [Time frame: 10 years]
- Time to first and subsequent occurrence of specified events. [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Male or female patients of any age, including minors, who have been diagnosed with aHUS
- Patients with or without an identified complement pathogenic variant or anti-complement factor antibody
- Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent \[if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)\].
- ADAMTS13 > 5%, if performed.
Exclusion criteria
- Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin producing Escherichia coli (STEC).
- Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees \[IRB/IEC\]).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 41 centers
- Clinical Trial Site 1 — Amiens
- Clinical Trial Site 2 — Amiens
- Clinical Trial Site — Angers
- Clinical Trial Site — Bayonne
- Clinical Trial Site — Bordeaux
- Clinical Trial Site — Brest
- Clinical Trial Site — Bron
- Clinical Trial Site — Caen
- … and 33 more centers
South Korea · 18 centers
Center list to be confirmed — check the primary protocol.
Belgium · 12 centers
- Clinical Trial Site — Brussels
- Clinical Trial Site — Brussels
- Clinical Trial Site — Brussels
- Clinical Trial Site (Adult) — Edegem
- Clinical Trial Site (Pediatric) — Edegem
- Clinical Trial Site (pediatric) — Ghent
- Clinical Trial Site (Adult) — Leuven
- Clinical Trial Site (pediatric) — Leuven
- … and 4 more centers
Australia · 11 centers
- Clinical Trial Site 1 — Westmead
- Clinical Trial Site 2 — Westmead
- Clinical Trial Site — Cairns
- Clinical Trial Site — Herston
- Clinical Trial Site — Woolloongabba
- Clinical Trial Site — Adelaide
- Clinical Trial Site — Heidelberg
- Clinical Trial Site — Parkville
- … and 3 more centers
United States · 9 centers
- Clinical Trial Site — Aurora
- Clinical Trial Site — Washington D.C.
- Clinical Trial Site — Gainesville
- Clinical Trial Site — Atlanta
- Clinical Trial Site — Chicago
- Clinical Trial Site — Boston
- Clinical Trial Site — St Louis
- Clinical Trial Site — Winston-Salem
- … and 1 more center
Italy · 9 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 9 centers
Center list to be confirmed — check the primary protocol.
Germany · 7 centers
- Clinical Trial Site — Essen
- Clinical Trial Site 1 — Hanover
- … and 5 more centers
Canada · 4 centers
- Clinical Trial Site — London
- Clinical Trial Site — Toronto
- Clinical Trial Site — Montreal
- Clinical Trial Site — Québec
Spain · 4 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 4 centers
Center list to be confirmed — check the primary protocol.
Russia · 3 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 3 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 3 centers
Center list to be confirmed — check the primary protocol.
Poland · 2 centers
Center list to be confirmed — check the primary protocol.
Denmark · 1 center
- Clinical Trial Site — Odense
Israel · 1 center
Center list to be confirmed — check the primary protocol.
Publications
- Gaeckler A, Al-Dakkak I, Saval N, Dieperink HH, Eygenraam M, Greenbaum LA, Isbel N, Walle JV. Effectiveness and Safety of Switching to Ravulizumab From Eculizumab in Kidney Transplant Recipients With Atypical Hemolytic Uremic Syndrome: A Global aHUS Registry Analysis. Clin Transplant. 2025 Sep;39(9):e70278. doi: 10.1111/ctr.70278. PMID 40875209
- Halimi JM, Al-Dakkak I, Anokhina K, Ardissino G, Licht C, Lim WH, Massart A, Schaefer F, Walle JV, Rondeau E. Clinical characteristics and outcomes of a patient population with atypical hemolytic uremic syndrome and malignant hypertension: analysis from the Global aHUS registry. J Nephrol. 2023 Apr;36(3):817-828. doi: 10.1007/s40620-022-01465-z. Epub 2022 Sep 24. PMID 36152218
- Woodward L, Johnson S, Walle JV, Beck J, Gasteyger C, Licht C, Ariceta G; aHUS Registry SAB. An innovative and collaborative partnership between patients with rare disease and industry-supported registries: the Global aHUS Registry. Orphanet J Rare Dis. 2016 Nov 21;11(1):154. doi: 10.1186/s13023-016-0537-5. PMID 27871301
- Licht C, Ardissino G, Ariceta G, Cohen D, Cole JA, Gasteyger C, Greenbaum LA, Johnson S, Ogawa M, Schaefer F, Vande Walle J, Fremeaux-Bacchi V. The global aHUS registry: methodology and initial patient characteristics. BMC Nephrol. 2015 Dec 10;16:207. doi: 10.1186/s12882-015-0195-1. PMID 26654630
- Belingheri M, Possenti I, Tel F, Paglialonga F, Testa S, Salardi S, Ardissino G. Cryptic activity of atypical hemolytic uremic syndrome and eculizumab treatment. Pediatrics. 2014 Jun;133(6):e1769-71. doi: 10.1542/peds.2013-2921. Epub 2014 May 19. PMID 24843058
- Ardissino G, Possenti I, Tel F, Testa S, Paglialonga F. Time to change the definition of hemolytic uremic syndrome. Eur J Intern Med. 2014 Feb;25(2):e29. doi: 10.1016/j.ejim.2013.12.002. Epub 2013 Dec 21. No abstract available. PMID 24360866
Identifiers
NCT: NCT01522183 · M11-001