Dataset from PERL: A Multicenter Clinical Trial of Allopurinol to Prevent GFR Loss in T1D

Despite improvements during the past 20 years in blood glucose and blood pressure control,
diabetic kidney disease remains one of the most important causes of health problems in
patients with diabetes. Novel treatments to complement blood glucose and blood pressure
control are urgently needed. The goal of this study is to see whether a medication called
allopurinol may help prevent loss of kidney function among people with type 1 diabetes.
Allopurinol has been used for many years to decrease high blood uric acid and treat gout - a
disease characterized by arthritis, especially of the foot joints. There is evidence
suggesting that allopurinol might also be useful in people with diabetes who have normal or
moderately impaired kidney function to decrease the risk of developing advanced kidney
disease in the future. To prove this beneficial effect of allopurinol, we will be conducting
an international clinical trial at eight diabetes centers, enrolling approximately 480
patients with type 1 diabetes who are at increased risk of developing kidney disease.
Participants will be randomly assigned to take allopurinol or placebo (inactive pill) for
three years, during which they will be followed through periodical visits. To prevent any
possible bias, neither the participants nor the clinical staff knows who is taking
allopurinol and who is taking the placebo. Kidney function will be measured at the beginning
and at the end of the treatment period to see whether patients taking allopurinol experience
a slower loss of kidney function over time as compared to those taking the inactive pill. If
this trial is successful, the reduction in health problems resulting from the prevention or
delay of kidney function loss due to the use of allopurinol would have a major impact on the
lives of type 1 diabetic patients as well as on society at large, significantly reducing the
human and financial costs associated with diabetic kidney disease. Because of the emphasis on
early intervention, the proposed trial, if successful, will establish a new paradigm in
treatments to slow or prevent progression towards end stage kidney disease in type 1 diabetes
far beyond anything achieved to date.