Study of cemdisiran in adult patients with IgAN
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy
IRAS ID
260387
Contact name
Jonathan Barratt
Contact email
Sponsor organisation
Anlylam Pharmaceuticals Inc.
Eudract number
2018-002716-27
Duration of Study in the UK
3 years, 8 months, 19 days
Research summary
IgA Nephropathy (IgAN),is a disease of the kidney & immune system. In IgAN, a faulty version of IgA is produced which triggers a reaction causing a build up of faulty IgA & immune proteins deposited in the kidneys. This can lead to activation of a system called ‘complement’ and this can lead to inflammation in the kidney & tissue damage.
The role of the kidney is to filter waste from blood. When the kidneys cannot function properly, they leak blood and protein into urine, often the first sign of IgAN.
Early symptoms can include cola- or tea-coloured urine, sometimes blood in urine, pain in the back, swelling in hands & feet, high blood pressure & tiredness.
The kidneys may stop working & may need long-term dialysis to replace kidney function Some people eventually need a kidney transplant.To date, no medications have been approved for the treatment of IgAN. The disease occurs and progresses for reasons that are not fully understood.
Cemdisiran, is an investigational medicine developed by Alnylam Pharmaceuticals, Inc. to treat IgAN. It may be able to lower the activity of the complement system and the effect it has on kidney tissue and function.
Available data & evaluation of the benefit-risk support continued investigation as a potential treatment for IgAN.
The study will evaluate the effect of cemdisiran on proteinuria, the effect of cemdisiran on remission of proteinuria, the effect of cemdisiran on hematuria and the safety & tolerability of Cemdisiran in patients with IgAN.
30 people from around the world will participate with 6 from the UK.
Study participation is 3 years 7 weeks or 2 years 7 weeks (if not in OLE).Procedures include medical history, physical exam, vital signs, ECG, Blood & urine samples.
This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study.
Lay Summary:
Primary results are available on CT.gov: https://clinicaltrials.gov/study/NCT03841448?term=ALN-CC5-005&rank=1&tab=results - Final results will be available on CT.gov and EudraCT within one year of study completion date.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0060
Date of REC Opinion
11 Jun 2019
REC opinion
Further Information Favourable Opinion