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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Hira
Siddiqui
+44 (0)1223 250709
hira.siddiqui@nhs.net
Dr
Katrina
Gatley
+44 (0)1223 349007
katrina.gatley1@nhs.net
Nephrotic syndrome, caused by minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS) are rare auto-immune kidney diseases that lead the patient to develop nephrotic syndrome and if untreated can result in substantial morbidity including kidney failure and death. All the current treatments have serious limitations and glucocorticoids are the mainstay of treatment in MCD/FSGS. Although they are effective in most of the patients, recurrent relapses happen in 75% of the patients when the steroid dose is reduced or withdrawn. Frequent relapses result in high cumulative steroid exposure, which in turn increases the risk of obesity, diabetes, infection and osteoporosis.
There is a critical need for steroid alternative treatments in MCD/FSG patients that are both effective and safe, and do not adversely affect kidney function. Rituximab is the most promising candidate treatment. It is currently a licensed treatment for other auto-immune diseases where it has an excellent safety profile. Moreover, randomised trial evidence already supports the use of rituximab in children with MCD/FSGS. This study, TURING, will assess if giving rituximab to an adult patient with nephrotic syndrome caused by MCD/FSGS is safe, effective to prevent relapses of the disease and determine how long patients remain well. TURING will help doctors to decide the best course of treatment for future patients.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. MCD or FSGS due to secondary causes, including obesity-driven hyperfiltration, remnant kidneys, malignancy of a type likely to be associated with MCD /FSGS and genetic polymorphisms known to be associated with nephrosis 2. MCD/FSGS secondary to malignancy, including lymphoproliferative disorders 3. Family history of MCD or FSGS in a first degree relative4. Previous rituximab within 18 months preceding Day 0 (SPPR), or 12 months if there is evidence of B cell return in peripheral lymphocyte subsets5. Previous cyclophosphamide within 6 months preceding Day 0 (SPPR)6. Prednisolone daily dose equal to or greater than 60mg, with a course length of greater than4 weeks, immediately prior to randomisation7. Evidence of current or past infection with Hepatitis B, C or HIV (unless appropriate prophylaxis is given and no replicating virus is detected)8. Positive serum pregnancy test (within 14 days prior to treatment with IMP in main trial and rituximab in OLP)9. Evidence of active severe infection10. Severe heart failure or severe, uncontrolled cardiac disease11. Pregnant or breast-feeding women12. Live vaccine administration in the four weeks prior to enrolment and while remaining on IMP treatment13. Previous/known hypersensitivity to prednisolone or IMP or to murine proteins (and any excipients as described in section 6.1 of the SmPC)14. Co-enrolment in another clinical trial of an investigational medicinal product15. Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial16. An increase in CNI dose in the four weeks preceding randomisation
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Katrina
Gatley
+44 (0)1223 349007
katrina.gatley1@nhs.net
Dr
Hira
Siddiqui
+44 (0)1223 250709
hira.siddiqui@nhs.net
The study is sponsored by Cambridge University Hospitals NHS Foundation Trust and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 17/83/06.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
