PROteKT
Research type
Research Study
Full title
Phase IIa, Randomised, Controlled, Open-Label Trial of Rosuvastatin for the Prevention of Aminoglycoside-Induced Kidney Toxicity in Children with Cystic Fibrosis
IRAS ID
137736
Contact name
Munir Pirmohamed
Contact email
Sponsor organisation
University of Liverpool
Eudract number
2014-002387-32
Research summary
Children with the genetic disease cystic fibrosis (CF) are prone to chest infection with a resistant bacteria called Pseudomonas aeruginosa. Treatment with a type of antibiotic called an aminoglycoside, can improve survival in these patients. However, exposure to these antibiotics can cause both short- and long-term kidney damage, and approximately one third of CF patients will have reduced kidney function by the time they’re adults. Developing a method to protect the kidneys during aminoglycoside treatment would enable patients to continue to benefit from their positive impacts, but reduce their risk of suffering kidney damage.
We believe that a medicine called rosuvastatin, which is normally used to treat people with high cholesterol, may be able to protect the kidneys from the damage caused by aminoglycosides. To help us find out whether this is true or not, we are doing this research study in children with CF getting treatment with an aminoglycoside called tobramycin.
This clinical trial will run at a number of hospitals in England where there are teams of specialists in looking after children with CF. It will compare two groups of children with CF: the treatment group will take a daily dose of rosuvastatin for the duration of their planned tobramycin treatment (usually 2 weeks) and the control group will receive no additional treatment. To show the effect on the kidney we will measure some substances in the urine, called biomarkers and a substance called creatinine in blood samples. We will compare the results of these tests between the two groups to see if there is a protective effect of rosuvastatin. To do these tests we will collect urine samples on each day, and blood tests on 4 occasions during the 2 week period. We will repeat these tests again 4 weeks after finishing treatment.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/1067
Date of REC Opinion
5 Aug 2014
REC opinion
Further Information Favourable Opinion