Clinical trials: Hemolytic Uremic Syndrome
aHUS
A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in aHUS Patients in South Korea
Primary objective To determine the clinical prognosis by identifying the disease course and severity by treatment with or without eculizumab in patients with aHUS in Korea.
- Trial name
- NCT05405777
- Where
- South Korea
- Volunteers
- 97 people
- Sponsor
- Handok Inc.
Diarrhea-Associated Hemolytic Uremic Syndrome, Pediatric Kidney Disease
A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS
Hemolytic Uremic Syndrome (HUS) is a foodborne disease which mainly affects children. It is caused by Escherichia coli bacteria, which release a toxin called Shiga toxin within the body.
- Conditions
- Diarrhea-Associated Hemolytic Uremic Syndrome, Pediatric Kidney Disease, Hemolytic-Uremic Syndrome
- Trial name
- NCT05569746
- Testing
- INM004, SoC
- Where
- 16 sites in Argentina
- Volunteers
- 57 people
- Sponsor
- Inmunova S.A.
Atypical Hemolytic Uremic Syndrome (aHUS)
Study of Ravulizumab in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS)
The purpose of the study is to assess the efficacy of ravulizumab to control disease activity in children and adolescents with aHUS who have not previously used a complement inhibitor (complement inhibitor treatment-naïve), as…
- Trial name
- NCT03131219
- Testing
- Ravulizumab
- Where
- 18 sites in United States, Belgium and 5 more
- Volunteers
- 34 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Atypical Hemolytic Uremic Syndrome (aHUS)
The Safety and Efficacy of Eculizumab in Japanese Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
Protocol is intended to characterize the overall safety and tolerability of eculizumab in this population.
- Trial name
- NCT01757431
- Testing
- Eculizumab
- Where
- 2 sites in Japan
- Volunteers
- 2 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Mucositis, Graft-versus-host Disease
Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX
A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and discontinued by day +180.
- Trial name
- NCT00360685
- Testing
- Tac+MTX, TAC + MMF
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Atypical Hemolytic Uremic Syndrome
Eculizumab to Cemdisiran Switch in aHUS
Atypical Hemolytic Uremic Syndrome (aHUS) is a rare, lifethreatening, chronic disease of complement-mediated thrombotic microangiopathy (TMA) characterized by acute onset of renal impairment, thrombocytopenia, and…
- Trial name
- DANCE (NCT03999840)
- Testing
- cemdisiran
- Where
- Italy
- Sponsor
- Mario Negri Institute for Pharmacological Research
Hairy Cell Leukemia
US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)
This study is being conducted to satisfy a post-marketing requirement (PMR) to provide evidence characterizing 1) the safety of moxetumomab pasudotox-tdfk in patients who are 65 years of age and older and/or 2) the safety of…
- Trial name
- PROXY (NCT04125290)
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- AstraZeneca
Atypical Hemolytic Uremic Syndrome
aHUS Observational Long Term Follow-Up
There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab.
- Trial name
- LTFU (NCT01522170)
- Where
- 56 sites in United States, Australia and 10 more
- Volunteers
- 94 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection, Hemolytic-Uremic Syndrome
Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E.
- Trial name
- HIKO-STEC (NCT05219110)
- Testing
- Infusion of 200% maintenance fluids as balanced crystalloid IV solution, Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution
- Where
- 26 sites in United States, Canada
- Volunteers
- 1,040 people
- Sponsor
- University of Calgary
Haemolytic and Uremic Syndrome
Azithromycin in Post Diarrheal Haemolytic and Uremic Syndrome
Post diarrheal hemolytic and uremic syndrome (D+HUS) is the first etiology of acute renal failure in children less than 5 years old in France.
- Trial name
- ZITHROSHU (NCT02336516)
- Testing
- Azithromycin
- Where
- France
- Volunteers
- 148 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Ultomiris-exposed Pregnant/ Postpartum, Pregnancy
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of…
- Conditions
- Ultomiris-exposed Pregnant/ Postpartum, Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS)
- Trial name
- NCT06312644
- Testing
- Ultomiris
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 75 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Atypical Hemolytic Uremic Syndrome
Evaluation of Potential Predictors of Disease Progression in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Including Genetics, Biomarkers, and Treatment
This was a prospective, open-label study with no participant randomization. Treatment for aHUS was observational and at the discretion of the treating physician.
- Trial name
- EVIDENCE (NCT02614898)
- Testing
- Eculizumab
- Where
- 24 sites in United States, Australia and 2 more
- Volunteers
- 67 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hemolytic Uremic Syndrome
Study of 'Vascular Competence' Profile and Endothelial Activation in the Hemolytic Uremic Syndrome in Children and Adults
The Hemolytic Uremic Syndrome (HUS) is a rare thrombotic microangiopathy (TMA), affecting both children and adults. HUS is characterized by the abnormal occurrence of diffuse thrombosis in the microcirculation resulting in the…
- Trial name
- SHU (NCT02904863)
- Testing
- Extra blood draw samples
- Where
- France
- Volunteers
- 19 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Hemolytic-Uremic Syndrome
Efficacy of INM004 in Children With STEC-HUS
The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS).
- Trial name
- NCT06389474
- Testing
- INM004
- Where
- 52 sites in Argentina, Belgium and 7 more
- Volunteers
- 220 people
- Sponsor
- Inmunova S.A.
Atypical Hemolytic Uremic Syndrome (aHUS)
A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
The objective of this retrospective trial is to assess safety and efficacy of eculizumab in aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.
- Trial name
- NCT01770951
- Where
- 23 sites in United States, Austria and 6 more
- Volunteers
- 30 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hemolytic-uremic Syndrome, Escherichia Coli Infections
Outbreak of Hemolytic Uremic Syndrome Linked to Escherichia Coli of Serotype O104:H4
The Hemolytic Uremic Syndrome (HUS) in its typical form occurs after a food born infection with a shiga-toxin secreting bacteria, usually Escherichia coli of the O157H7 serotype.
- Trial name
- SHU O104 CUB (NCT01406288)
- Testing
- HUS standard coverage care (including in ICU)
- Where
- France
- Volunteers
- 9 people
- Sponsor
- University Hospital, Bordeaux
Hemolytic-Uremic Syndrome
Usefulness of a Diagnostic Algorithm to Diagnose Thrombotic Microangiopathies in Pregnancy
Haemolytic uremic syndrome (HUS) is defined by the presence of the classic triad of non-immune microangiopathic hemolytic anemia (negative direct Coombs), thrombocytopenia and acute renal failure.
- Trial name
- NCT03580941
- Where
- Colombia
- Volunteers
- 75 people
- Sponsor
- Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia
ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)
To Characterize the Safety and Tolerability of Eculizumab in Two Japanese aHUS Patients
This protocol is intended to formally collect data on the treatment of aHUS with eculizumab in Japanese patients.
- Trial name
- NCT01755429
- Where
- 2 sites in Japan
- Volunteers
- 2 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hemolytic Uremic Syndrome of Childhood
Eculizumab in Shiga-toxin Related Hemolytic and Uremic Syndrome Pediatric Patients - ECULISHU
The investigators aim to perform the first controlled randomized prospective study using ECZ in pediatric STEC-HUS. This is of great interest as there is still no efficient specific therapy in that potentially devastating…
- Trial name
- ECULISHU (NCT02205541)
- Testing
- Eculizumab
- Where
- 18 sites in France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Toulouse
Atypical Hemolytic Uremic Syndrome(aHUS)
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
This is a China, non-interventional, observational study and will follow the Good Phar-macoepidemiology Practices guidelines. This study will enrol paediatric and adult patients diagnosed with aHUS who will be treated according…
- Trial name
- NCT06099236
- Where
- 26 sites in China
- Volunteers
- 367 people
- Sponsor
- AstraZeneca