Atypical Hemolytic Uremic SyndromeREACHNCT07218536
The Burden of Atypical Hemolytic Uremic Syndrome and The Clinical Characteristics of Patients in Egyptian Hospitals A Multicenter, Observational, Retrospective Cohort Study in Egypt
An observational study of Atypical Hemolytic Uremic Syndrome, run by AstraZeneca at 6 sites in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atypical Hemolytic Uremic Syndrome
- How many people
- 200 participants
- Where
- 6 sitesEgypt
- Study dates
- 13 Oct 2025to 6 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with TMA between 01-Jan-2010 and 31-Dec-2023 regardless of administered treatment. Medical records of all patients fulfilling the eligibility criteria will be collected.
Who may be able to join
- Male or female patients aged one month or older who have been diagnosed with TMA between 01-Jan-2010 and 31-Dec-2023.
Who cannot join
- None. All records of patients with TMA will be screened for aHUS diagnosis.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Egypt6 sites
Research Site
Alexandria
Research Site
Asyut
Research Site
Cairo
Research Site
New Cairo
Research Site
Tanta
Research Site
Zagazig
About this study
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.
Read more
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.
- Conditions
- Atypical Hemolytic Uremic Syndrome
- Medical subject headings
- Atypical Hemolytic Uremic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic and clinical characteristics of patients with aHUS.
Duration between the first aHUS treatment initiation and aHUS diagnosis
Measured: 10 Years
Secondary outcomes (4)
The prevalence of patients diagnosed with aHUS
The prevalence of patients diagnosed with aHUS among the total number of patients with TMA in the participating hospitals.
Measured: 10 Years
clinical outcomes of current treatment
Overall survival rate (OS)
Measured: 10 Years
aHUS Treatment Patterns
Treatment regimen(s)
Measured: 10 Years
aHUS Treatment Outcomes
Overall Survival: defined as the proportion of people still alive at a given time point after treatment initiation
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start13 Oct 2025
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Hemolytic Uremic SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218536
- Sponsor's protocol ID
- D928BR00001
- Acronym
- REACH
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Burden of Atypical Hemolytic Uremic Syndrome and The Clinical Characteristics of Patients in Egyptian Hospitals A Multicenter, Observational, Retrospective Cohort Study in Egypt
- ClinicalTrials.gov ID
- NCT07218536
- Acronym / sponsor ID
- REACH / D928BR00001
- Conditions
- Atypical Hemolytic Uremic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with TMA between 01-Jan-2010 and 31-Dec-2023 regardless of administered treatment. Medical records of all patients fulfilling the eligibility criteria will be collected.
Key inclusion criteria (1 listed)
- Male or female patients aged one month or older who have been diagnosed with TMA between 01-Jan-2010 and 31-Dec-2023.
Key exclusion criteria (1 listed)
- None. All records of patients with TMA will be screened for aHUS diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic and clinical characteristics of patients with aHUS.
Time frame: 10 Years
Duration between the first aHUS treatment initiation and aHUS diagnosis
4 secondary outcomes
The prevalence of patients diagnosed with aHUS
Time frame: 10 Years
clinical outcomes of current treatment
Time frame: 10 Years
aHUS Treatment Patterns
Time frame: 10 Years
aHUS Treatment Outcomes
Time frame: 10 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atypical Hemolytic Uremic Syndrome, run by AstraZeneca at 6 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and clinical characteristics of patients with aHUS. (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.