Study of Eculizumab in Adults with Hypertensive Emergency-Related Hemolytic Uremic Syndrome Requiring Dialysis or with Severe Kidney Problems

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What is this study about?

This study focuses on Hemolytic Uremic Syndrome associated with hypertensive emergency, a condition where severe high blood pressure causes damage to blood cells and kidneys. The study will evaluate a medication called eculizumab, which is given through intravenous infusion, in addition to standard blood pressure control treatment. This rare condition can lead to kidney failure requiring dialysis and may affect other organs including the brain, heart, and eyes.

The purpose of this research is to determine if early treatment with eculizumab can help prevent the need for ongoing dialysis in patients with severe kidney problems. The study will last for approximately 13 weeks, during which participants will receive either eculizumab or standard treatment alone. The maximum daily dose of eculizumab will be 1200 mg, with a total maximum dose of 9600 mg over the treatment period.

Patients will be monitored for various health indicators, including kidney function, blood cell counts, and potential complications. The study will track how quickly patients recover from their condition and whether they still need dialysis after several months of treatment. Researchers will also examine how the body’s complement system (a part of the immune system) responds to the treatment and look for specific genetic variations that might affect treatment outcomes.

1 Initial evaluation

You will be evaluated for severe kidney problems requiring dialysis or having high levels of creatinine in your blood.

The doctor will check if you have high blood pressure (above 180/110 mmHg) and related complications.

Blood tests will be performed to check for anemia and other blood-related issues.

2 Treatment assignment

You will be randomly assigned to receive either Eculizumab with standard blood pressure treatment or standard blood pressure treatment alone.

If you are assigned to receive Eculizumab, it will be given through an intravenous line (directly into your vein).

3 Follow-up visits

Week 1: Blood samples will be taken to check complement levels

Week 2: Evaluation of blood-related complications

Week 4: Additional blood tests for complement levels

Week 13: Further complement level testing

Month 3: Assessment of kidney function and need for dialysis

Month 6: Major evaluation of kidney function and treatment response

Month 12: Final assessment of kidney function

4 Additional monitoring

Regular checks for infections that might require hospitalization

Monitoring of kidney function and blood pressure

If needed, a kidney biopsy may be performed to examine tissue damage

5 Study duration

The study will continue until February 2027

Female participants must use effective contraception during the study and for 5 months after the last dose of Eculizumab

Who Can Join the Study?

Must be 18 years or older
Must have been hospitalized within the last 10 days with the following conditions:
- Acute kidney failure requiring dialysis or having high blood creatinine levels
- Blood cell breakdown showing anemia (low red blood cells), low platelets, and signs of blood cell destruction
- Severe high blood pressure with systolic pressure above 180mmHg and/or diastolic pressure above 110mmHg
- Evidence of organ damage that may include:
  - Brain symptoms like headaches, confusion, or brain swelling
  - Heart problems like chest pain, breathing difficulties, or heart failure
  - Eye problems like vision changes or damage to the retina
For women who can become pregnant: Must use effective birth control during the study and for 5 months after the last treatment
Must be registered with a social security system
Must be able to understand and sign an informed consent form

Who Cannot Join the Study?

Age below 18 years or above 65 years
Pregnancy or breastfeeding
Previous history of organ transplantation
Active cancer or ongoing cancer treatment
Severe heart disease
Active infections, including meningitis (infection of the brain and spinal cord membranes)
Known allergies to Eculizumab or similar medications
Participation in other clinical trials within the last 30 days
Uncontrolled high blood pressure despite medication
Severe liver disease
Active autoimmune conditions other than aHUS (atypical Hemolytic Uremic Syndrome)
History of drug or alcohol abuse within the past year
Mental conditions that could interfere with following study procedures
Inability to provide informed consent
Life expectancy less than 6 months due to other medical conditions

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Cflssc Hcqqrkhwvlo Uafvjbqrpntoe Rdfms	Reims	France
Acssrtgicj Pcbsxmcw Hzxeopzh Dz Mswoavhff	Marseille	France
Cghdfw Hztepkiicqd Rtguaysl Utcxbgkbsiksz Dv Tawbo	Tours	France
Ifjkixgo dd Cqzqukwyssyw Hjsnizvoxsj Uivntelacctur dy Sxdok Eldvkzp (ahpuogt	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	13.02.2024

Trial locations

Investigated drugs:

Eculizumab

Eculizumab is a medication that works by blocking part of the body’s immune system called the complement system. It is used to treat rare conditions affecting blood cells and kidneys. In this trial, it is being studied for treating patients with hypertensive emergency-associated hemolytic uremic syndrome (HEaHUS), a serious condition that affects the kidneys. The medication is given in addition to standard blood pressure control treatments to help prevent kidney damage and reduce the need for dialysis.

Standard blood pressure control treatments are also used in this trial alongside Eculizumab. These treatments help manage dangerously high blood pressure levels that can cause damage to the kidneys and other organs.

Investigated diseases:

Atypical haemolytic uraemic syndrome

Atypical Hemolytic Uremic Syndrome (aHUS) – A rare condition that occurs when tiny blood clots form in small blood vessels throughout the body, particularly affecting the kidneys. The condition leads to the destruction of red blood cells, low platelet count, and kidney damage. aHUS can be triggered by various factors, including genetic mutations affecting the complement system. The disease typically manifests with symptoms such as decreased urine output, fatigue, and high blood pressure. It can progress to cause severe kidney dysfunction, potentially requiring dialysis.

Hypertensive Emergency (HE) – A severe elevation in blood pressure that leads to organ damage, particularly affecting the kidneys, heart, and brain. The condition develops rapidly and causes damage to blood vessels throughout the body. During a hypertensive emergency, blood pressure readings are typically extremely high, causing immediate strain on organs. The condition can result in significant kidney dysfunction and other organ complications.

Trial ID:

2024-516402-32-00

Protocol code:

APHP211039

NCT ID:

NCT05726916

Trial Phase:

Therapeutic confirmatory (Phase III)

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