Article No. 445
13 July 2021
Hoffmann Roche has announced its pediatric trial of crovalimab for aHUS. It is featured on the ClinicalTrials.Gov website and can be found at this link HERE.
Although its status is currently “not yet recruiting” the plan is to study the effectiveness and safety of the drug on 35 children, beginning in October this year. The estimated completion date is December 2025.
There will be three study arms. Firstly those who have not been treated with a complement inhibitor before i.e. naive , those who choose to switch from eculizumab treatment and finally those have been pre treated but for whom eculizumab did not work or who have withdrawn from treatment
27 hospital locations in 11 countries have been listed where recruitment will take place including
| United States, Florida | |
| Joe DiMaggio Children’s Hospital | |
| Hollywood, Florida, United States, 33021 | |
| United States, Nebraska | |
| University of Nebraska; Pediatric Nephrology | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New York | |
| SUNY at Stony Brook | |
| Stony Brook, New York, United States, 11790 | |
| United States, Ohio | |
| Cincinnati Children’s Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Belgium | |
| UZ Gent | |
| Gent, Belgium, 9000 | |
| UZ Leuven Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| Brazil | |
| Santa Casa de Belo Horizonte; Centro de Hemodiálise | |
| Belo Horizonte, MG, Brazil, 30150-320 | |
| UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu | |
| Botucatu, SP, Brazil, 18618-686 | |
| Inst. Da Criança- Faculdade de Medicina Usp; Unidade de Pneumologia | |
| Sao Paulo, SP, Brazil, 05403-900 | |
| Canada, Quebec | |
| CHU Sainte-Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| China | |
| Peking University First Hospital | |
| Beijing City, China, 100034 | |
| Beijing Children’s Hospital, Capital Medical University | |
| Beijing City, China, 100045 | |
| The children’s hospital , Zhejiang university school of medicine | |
| Hangzhou, China | |
| Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech | |
| Wuhan, China, 430030 | |
| France | |
| Hôpital Arnaud de Villeneuve; Néphrologie pédiatrique | |
| Montpellier, France, 34295 | |
| Gh Necker Enfants Malades; Nephrologie | |
| Paris, France, 75743 | |
| Israel | |
| Rambam medical Center; Pediatric Nephrology | |
| Haifa, Israel, 3109601 | |
| Italy | |
| Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico; Nefrologia Pediatrica | |
| Milano, Lombardia, Italy, 20122 | |
| Japan | |
| Aichi Children’s Health and Medical Center | |
| Aichi, Japan, 474-8710 | |
| Hiroshima Prefectural Hospital | |
| Hiroshima, Japan, 734-8530 | |
| Yokohama City University Medical Center | |
| Kanagawa, Japan, 232-0024 | |
| Okinawa Prefectural Nanbu Medical Center & Children’s Medical Center | |
| Okinawa, Japan, 9011193 | |
| Poland | |
| Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy | |
| Gdansk, Poland, 80-294 | |
| Instytut “Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii | |
| Lodz, Poland, 93-338 | |
| Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego | |
| Warszawa, Poland, 04-730 | |
| Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii | |
| Zabrze, Poland, 41-800 | |
| Spain | |
| Hospital Universitario Virgen del Rocio; Servicio de Nefrologia | |
| Sevilla, Spain, 41013 | |
The usual study outcomes apply , the prime being a complete TMA response by week 25 in those naive to complement inhibitor treatment. There are 23 secondary outcome measures at 25 weeks and up to 8 years. Nothing which asks the patient their views on the experience and perception of the method and interval of treatment delivery. This drug has to be self injected, which is novel to aHUS treatment but common in diabetes treatment.
The usual inclusion/exclusion criteria apply.
Four or eight years of data will not be needed to make an application for marketing approval of crovalimab but 25 weeks data will be needed from the last patient recruited.
Then work can be begin on revealing the outcomes in clinical publications which will take time to do but it is unlikely to be before 2023. If there is a positive outcome further time will be taken in going through licensing processes, e.g. FDA ,before health policy makers get to rule on funding it for patients,
