Sunil V Badve 1, Elaine M Pascoe 1, Anushree Tiku 1, Neil Boudville 1, Fiona G Brown 1, Alan Cass 1, Philip Clarke 1, Nicola Dalbeth 1, Richard O Day 1, Janak R de Zoysa 1, Bettina Douglas 1, Randall Faull 1, David C Harris 1, Carmel M Hawley 1, Graham R D Jones 1, John Kanellis 1, Suetonia C Palmer 1, Vlado Perkovic 1, Gopala K Rangan 1, Donna Reidlinger 1, Laura Robison 1, Robert J Walker 1, Giles Walters 1, David W Johnson 1, CKD-FIX Study Investigators
Main idea: In patients with chronic kidney disease and a high risk of progression, urate-lowering treatment with allopurinol did not slow the decline in eGFR as compared with placebo.
Background: Elevated serum urate levels are associated with the progression of chronic kidney disease. Whether urate-lowering treatment with allopurinol can attenuate the decline of the estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease who are at risk for progression is not known.
Methods: In this randomized, controlled trial, we randomly assigned adults with stage 3 or 4 chronic kidney disease and no history of gout to receive allopurinol or a placebo. The primary outcome was the change in eGFR from randomization to week 104, calculated with the Chronic Kidney Disease Epidemiology Collaboration creatinine equation.
Results: Enrollment was stopped because of slow recruitment after 369 of 620 intended patients were randomly assigned to receive allopurinol (185 patients) or placebo (184 patients) Three patients per group withdrew immediately after randomization. Serious adverse events were reported in 84 of 182 patients (46%) in the allopurinol group and in 79 of 181 patients (44%) in a placebo group. The change in eGFR did not differ significantly between the allo- and placebo groups.