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Center for Global Research Data

Reanalysis of CARES study to investigate the changes of estimated glomerular filtration rate after long-term febuxostat or allopurinol treatment in gout patients

Lead Investigator: Byeongzu Ghang, Jeju National University Hospital
Title of Proposal Research: Reanalysis of CARES study to investigate the changes of estimated glomerular filtration rate after long-term febuxostat or allopurinol treatment in gout patients
Vivli Data Request: 7388
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Hyperuricemia is elevated uric acid in the blood, above a certain level, crystal deposits may occur leading to pain and swelling in the joints known as gout. Hyperuricemia is also associated with various health conditions such as heart disease, diabetes mellitus, and kidney disease. Of these, chronic kidney disease (CKD) has been identified as a major public health concern worldwide. Hyperuricemia is significantly associated with development and progression of CKD. Several possible mechanisms explaining this relationship have been suggested, however, it is still unclear whether hyperuricemia plays a causative role in the progression of CKD, or is an indirect marker of decreased kidney function.
Under the hypothesis that hyperuricemia is a potentially modifiable risk factor for the progression of CKD, there has been an expectation that the control of hyperuricemia using urate-lowering therapy (ULT) will have a beneficial effect on slowing the progression of CKD. There have been numerous small, single-center studies that have shown that use of ULT delayed CKD progression in patients with hyperuricemia. However, three recent multicenter, randomized controlled trials, not targeting gout patients, have not shown beneficial effect of a ULT on slowing the progression of CKD. Therefore, there is controversy over the role of ULT in the progression of CKD.

Requested Studies:

A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities
Data Contributor: Takeda
Study ID: NCT01101035
Sponsor ID: TMX-67_301