Data

The CKD-FIX Trial: Controlled trial of slowing of Kidney Disease progression From the Inhibition of Xanthine oxidase

Australasian Kidney Trials Network, The University of Queensland

Dataset description

A randomised, double-blind, controlled trial to assess the effect of xanthine oxidase inhibitor, allopurinol, on the glomerular filtration rate (eGFR) in patients with stage 3-4 Chronic Kidney Disease Chronic kidney disease (CKD), defined as an eGFR less than 60 ml/min/1.73 m2 and/or the presence of kidney damage (albuminuria or proteinuria) for at least 3 months, is a major public health problem affecting approximately 1.6 million Australian adults. Of these affected individuals, approximately 930,000 have stages 3-4 CKD (eGFR 15-60 mL/min/1.73 m2). CKD patients have a greatly increased risk of adverse renal and cardiovascular (CV) outcomes, even in its early stages. CKD patients are at increased risk of progression to end-stage kidney disease (ESKD). The incidence of ESKD is increasing in Australia by 6% per annum. Apart from an increased risk of ESKD, the presence of CKD is one of the most potent known risk factors for cardiovascular disease (CVD), such that individuals with CKD are more likely to die, mostly from CVD, than survive to the point of needing dialysis or kidney transplantation. A reduction in eGFR < 60 ml/min/1.73 m2 is associated with increased risks of all-cause and CV mortality. The CKD-FIX trial aims to critically examine the efficacy and safety of allopurinol as an agent to slow the progression of chronic kidney disease (CKD).
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The CKD-FIX Trial: Controlled trial of slowing of Kidney Disease progression From the Inhibition of Xanthine oxidase

Brief Summary

Chronic kidney disease (CKD), defined as an eGFR <60 ml/min/1.73 m2 and/or the presence of kidney damage (albuminuria or proteinuria) for at least 3 months, is a major public health problem affecting approximately 1.6 million Australian adults. Of these affected individuals, approximately 930,000 have stages 3-4 CKD (eGFR 15-60 mL/min/1.73 m2). CKD patients have a greatly increased risk of adverse renal and cardiovascular (CV) outcomes, even in its early stages. CKD patients are at increased risk of progression to end-stage kidney disease (ESKD). The incidence of ESKD is increasing in Australia by 6% per annum. Apart from an increased risk of ESKD, the presence of CKD is one of the most potent known risk factors for cardiovascular disease (CVD), such that individuals with CKD are more likely to die, mostly from CVD, than survive to the point of needing dialysis or kidney transplantation. A reduction in eGFR <60 ml/min/1.73 m2 is associated with increased risks of all-cause and CV mortality. The CKD-FIX trial aims to critically examine the efficacy and safety of allopurinol as an agent to slow the progression of chronic kidney disease (CKD).

Inclusion Criteria

  • 1. Adult (age greater than or equal to 18 years) 2. CKD stage 3 or 4 (eGFR 15 to 59 mL/min/1.73 m2) 3. Random urine albumin to creatinine ratio greater or equal to 30mg/mmol OR Evidence of progression of CKD (decrease in eGFR greater than or equal to 3.0 mL/min/1.73 m2 during the preceding 12 months, calculated as the difference between the first and last tests, based on minimum of 3 blood tests with each test done at least 4 weeks apart). For diagnosis of CKD and determination of eGFR decline, eGFR estimates by either MDRD or CKD-EPI equation can be used according to the local practice.

Study Type

  • Interventional

Ethics Approval

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

Individual participant data that underlie the results reported in the primary publication, after de-identification (text, tables, figures and appendices). Medicare and all other administrative data will not be available.

When will data be available?

Beginning 2 years after the publication of all pre-specified analyses. There is no set end date for data sharing.

Available to whom?

Researchers with a methodologically sound proposal that has been approved by the AKTN Data Sharing Committee.

Available for what types of analyses?

To achieve the aims in the approved proposal.