EARLY PRO-TECT Alport XXL
Research type
Research Study
Full title
European initiative to slow down renal failure in patients with Alport syndrome - EARLY PRO-TECT Alport XXL
IRAS ID
305242
Contact name
Rachel Lennon
Contact email
Sponsor organisation
Universitätsmedizin Göttingen
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT02378805, ClinicalTrials.gov
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
Alport syndrome is the second most common single gene disorder cause of kidney failure. Children with Alport syndrome develop kidney failure early in life. Renin–angiotensin–aldosterone system (RAAS) inhibition is frequently used as a treatment for children who have symptoms of kidney damage associated with this condition, and can help to delay the start of renal failure. However this medication is currently not licensed for use in this population.
The EARLY PRO-TECT Alport trial conducted in Germany was the first trial of it's type to look at the safety and effectiveness of RAAS-inhibition medication in children with Alport syndrome, the findings were positive but due to the small number of children in the trial further research is needed to support an application for the medication to be licensed for use in this population.
The aim of the planned study is to look at outcomes and side effects over a longer time period for all children who took part in the German trial. The study also aims to review previously collected and available information on children with Alport Syndrome from Hospitals across the world to increase the quality of the original trial results.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/PR/0217
Date of REC Opinion
8 Apr 2022
REC opinion
Further Information Favourable Opinion