Home » Trials » SLCTR/2017/026 » Protocols
Date
2020-01-29
Protocol
Protocol changed
Item Changed
Inclusion criteria
Previous Version
Males and females, aged 21 to 65 years eGFR equal or less than 60ml/min/1.73m2 and more than 15 ml/min/1.73m2 Probable and confirmed CKDu according to Ministry of Health, Sri Lanka, guidelines Not on renal replacement therapy Not on urate lowering therapy other than Allopurinol Laboratory results of serum uric acid within the study cut off (>6mg/dl for males , >5 mg/dl for females)
Next Version
eGFR equal or less than 60ml/min/1.73m2 and more than 10ml/min/1.73m2 Age 21-75 years Serum bicarbonate and urine PH was included to identify any associates with renal tubular dysfunction. There were several technical issues as well as patient compliance issues due to complicated sample collection protocol and urine volumes. Both were abandoned and very unlikely to have impact on outcome. HsCRP was steady during the first year of follow up and not required to check frequently. Accordingly it has been changed to annual assessment.