The Burden of Atypical Hemolytic Uremic Syndrome and The Clinical Characteristics of Patients in Egyptian Hospitals A Multicenter, Observational, Retrospective Cohort Study in Egypt

NCT ID: NCT07218536

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-13

Study Completion Date

2026-09-30

Brief Summary

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Atypical hemolytic uremic syndrome (aHUS) is a rare, progressive, and life-threatening disease that occurs at any age, with incidence rate of 0.75 to 2.0 cases per million population per year. aHUS is a thrombotic microangiopathy (TMA) commonly caused by dysregulation of the complement system, affecting several organs, especially the kidneys. aHUS can be familial or sporadic, and approximately 50% to 60% of patients have specific identifiable genetic complement mutations and antibodies.

Although aHUS is a rare disease, it has a significant impact on the quality of life because of its poor prognosis: a 25% global mortality rate; more than 50% of untreated patients advance to endstage renal disease (ESRD); and more than 75% of adults with renal failure require prompt dialysis. The risk of relapse is also high in many patients, either in the native or transplanted kidneys, so long-term management and close monitoring are essential.

Advancements in aHUS therapies, especially the availability of anti-complement therapy, have enhanced the natural course of aHUS through hematologic remission induction, kidney function stabilization or improvement, and graft failure prevention. Since complement inhibitors are still unavailable in Egypt, it is important to understand the aHUS manifestations of pediatrics and adults in Egyptian hospitals, aiming for early diagnosis and proper management.

In this study, we primarily aim to describe the aHUS burden on the patients by gathering their demographic and clinical characteristics, documented disease course, and long-term complications. Our secondary objectives include an estimate of the prevalence of patients diagnosed with aHUS out of all patients with TMA and gathering information about the clinical outcomes of available therapies in real-world settings, as there is no data from the country on aHUS management.

Detailed Description

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Conditions

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Atypical Hemolytic Uremic Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male or female patients aged one month or older who have been diagnosed with TMA between 01-Jan-2010 and 31-Dec-2023.

Exclusion Criteria

* None. All records of patients with TMA will be screened for aHUS diagnosis.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Al Mansurah, , Egypt

Site Status NOT_YET_RECRUITING

Research Site

Alexandria, , Egypt

Site Status RECRUITING

Research Site

Asyut, , Egypt

Site Status RECRUITING

Research Site

Cairo, , Egypt

Site Status RECRUITING

Research Site

New Cairo, , Egypt

Site Status NOT_YET_RECRUITING

Research Site

New Cairo, , Egypt

Site Status RECRUITING

Research Site

Tanta, , Egypt

Site Status RECRUITING

Research Site

Zagazig, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

Other Identifiers

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D928BR00001

Identifier Type: -

Identifier Source: org_study_id

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