Effect of hydroxychloroquine on progression of diabetic kidney disease in type 2 diabetes mellitus patients: An open labelled randomized controlled trial (pilot study)

Following informed consent, patients will be randomized into two groups. One group will be started on HCQ once daily with dose adjustments as necessary to a maximum dose of 400mg once daily along with standard therapy. Other group will only receive standard therapy. All patients will be assessed at hospital initially and 3 months and 6 months from initial assessment. Each visit includes interview, physical examination and laboratory investigations. Dosage of drugs for the treatment of diabetes and hypertension will be adjusted to maintain good glycaemic and blood pressure control. ACE inhibitors or ARB’s can be added in both groups as necessary. The following investigations will be carried out initially and at 3 months and 6 months- ECG, HbA1C, fasting and post prandial blood sugars, fundoscopy, serum creatinine level, liver function tests and urinary albumin creatinine ratio. IL-6 and hsCRP will be done initially and at 6 months.

 Estimated Glomerular filtration rate (eGFR) can be measured using Modification of Diet in Renal Disease (MDRD) Study formula:

eGFR= 186 x (Creatinine in mg/ dL)- 1.154 x (Age) - 0.203 x (0.742 if female)

 Any adverse events during the course of study will be noted and treated accordingly.