Phase II Placebo-Controlled Study of Atacicept in IgA Nephropathy
Research type
Research Study
Full title
A Phase II, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy
IRAS ID
219130
Contact name
Eric Dollins
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2016-002262-31
Clinicaltrials.gov Identifier
122,043, IND Number
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
This Phase II, multicentre, double-blind, placebo-controlled (DBPC) parallel arm study has 2 parts. \n\nAtacicept is an investigational drug that is being evaluated for the treatment of patients with immunoglobulin A nephropathy (IgAN). Nephropathy is a broad medical term to denote disease or damage to the kidney). Investigational means that it has not been approved by any health authority (government authorities) and is still being tested for safety and effectiveness. Part A will look at how safe the study drug is, and what potential side effects it may cause. It will also look at what the study drug does to the body (known as “pharmacodynamics”), how the body processes the study drug (known as “pharmacokinetics”), and how the immune system responds to the study drug. Part B will look at how effective the study drug is at reducing certain symptoms of IgAN when it is used at different doses. In particular, it will look at whether the study drug can reduce the amount of protein passed in the urine as a result of IgAN. The study will also look at how the study drug affects the function of the kidneys, how safe the study drug is, and what side effects it causes in patients with IgAN. \n\nBoth parts of the study will compare the study drug to a placebo (something that looks the same as the study drug but contains no active medication). Placebos are used in clinical research studies to check that any effects seen from the study drug are real.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0011
Date of REC Opinion
22 Feb 2017
REC opinion
Further Information Favourable Opinion