estimated Glomerular Filtration Rate (eGFR)
Calculated from serum creatinine (mg/dl) using the CKD-EPI formula. Intended for evaluation of efficacy of metformin versus placebo.
Slope of eGFR
Change in eGFR from randomization to 6 months by incorporating eGFR at all timepoints in study between baseline and 6 months post-randomization. eGFR calculated from serum creatinine (mg/dl) using the CKD-EPI formula. Intended for evaluation of efficacy of metformin versus placebo.
Urine protein:creatinine ratio
Calculated ratio of urine protein and creatinine, each collected from the electronic medical record. Intended for evaluation of clinical efficacy of metformin versus placebo.
Slope of urine protein:creatinine ratio
Change in urine protein:creatinine ratio from randomization to 6 months by incorporating urine protein:creatinine ratio at all timepoints in study between baseline and 6 months post-randomization. Intended for evaluation of clinical efficacy of metformin versus placebo.
Complete remission
Calculated as the number of patients in complete remission, defined as <0.5 gm urine protein excretion over 24 hours, or urine protein creatinine ratio < 0.5 at 6 months post-randomization. Intended for evaluation of clinical efficacy of metformin versus placebo.
Complete or partial remission
Calculated as the number of patients with complete remission (defined as <0.5 gm urine protein excretion over 24 hours, or urine protein creatinine ratio < 0.5) or partial remission (>50% reduction in proteinuria from pre-randomization). Intended for evaluation of clinical efficacy of metformin versus placebo.
Discontinuation of study drug
Number of patients who discontinued study drug for any reason within 6 months of randomization. Intended for evaluation of patient compliance of metformin use.
Modified Kidney Disease Quality of Life (KDQOL) score
Calculated as the mean (standard deviation) of all total scores. Total scores are calculated by combining scores of 8 subsections of the KDQOL, and range from 0 - 163, with higher scores representing better quality of life. Intended for evaluation of adverse effects of metformin versus placebo.
Modified Kidney Disease Quality of Life (KDQOL) score
Calculated as the mean (standard deviation) of all total scores. Total scores are calculated by combining scores of 8 subsections of the KDQOL, and range from 0 - 163, with higher scores representing better quality of life. Intended for evaluation of adverse effects of metformin versus placebo.
Hypoglycemia symptom scores
Calculated as the mean (standard deviation) of all total scores. Total scores are calculated by combining scores of 6 subsections of the questionnaire, and range from 0 - 18, with higher scores representing greater symptoms. Intended for evaluation of adverse effects of metformin versus placebo.
Gastrointenstinal symptom scores
Calculated as the mean (standard deviation) of all total scores. Total scores are calculated by combining scores of 15 subsections of the questionnaire, and range from 0 - 105, with higher scores representing greater symptoms. Intended for evaluation of adverse effects of metformin versus placebo.
Gastrointenstinal symptom scores
Calculated as the mean (standard deviation) of all total scores. Total scores are calculated by combining scores of 15 subsections of the questionnaire, and range from 0 - 105, with higher scores representing greater symptoms. Intended for evaluation of adverse effects of metformin versus placebo.
Kidney biopsy fibrosis scores
Evaluation of kidney fibrosis as measured by quantification of Masson's Trichrome staining under microscopy of biopsy at 6 months post-randomization. Scores will be grouped by the following: <10%, 10-25%, 25-50%, > 50%. Intended for evaluation of clinical efficacy of metformin versus placebo.
Number of patients with Lactate levels>2.5
As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo.
Number of patients with Lactate levels>5
As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo.
Number of patients with Vitamin B12 levels <lower limit of Normal
As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo.
Number of patients with serum glutamic-oxaloacetic transaminase (SGOT) >2 fold increase
As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo.
Number of patients with Serum Glutamic Pyruvic Transaminase (SGPT) >2 fold increase
As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo.
Number of patients with Serum amyloid P component (SAP) >2 fold increase
As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo.
Number of patients with Bililirubin-Total >2
As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo.
Number of patients with Bilirubin indirect >1
As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo.
Number of patients with hemoglobin (Hb) <9
As determined from the electronic medical record. Intended for evaluation of disease progression and adverse effects of metformin versus placebo.
Number of patients with hematocrit (Hct) <27
As determined from the electronic medical record. Intended for evaluation of disease progression and adverse effects of metformin versus placebo.
Number of patients with mean corpuscular volume (MCV) >100
As determined from the electronic medical record. Intended for evaluation of disease progression and adverse effects of metformin versus placebo.
Number of patients with Total White Blood Cells (WBC) <1500
As determined from the electronic medical record. Intended for evaluation of disease progression and adverse effects of metformin versus placebo.
Slope of Urine Nphs2
Change in urine podocin mRNA(Nphs2), measured as number of molecules detected by qPCR in the collected urine pellet over the creatinine concentration. Slope measured by incorporating nphs2 measurements at all timepoints in study between baseline and 6 months post-randomization. Intended for evaluation of efficacy of metformin versus placebo.
Slope of Urine Aqp2
Change in urine Aquaporin-2 mRNA(Aqp2), measured as number of molecules detected by qPCR in the collected urine pellet over the creatinine concentration. Slope measured by incorporating Aqp2 measurements at all timepoints in study between baseline and 6 months post-randomization. Intended for evaluation of efficacy of metformin versus placebo.
Slope of Urine Tgfb1
Change in urine transforming growth factor-beta1 mRNA (Tgfb1), measured as number of molecules detected by qPCR in the collected urine pellet over the creatinine concentration. Slope measured by incorporating Tgfb1 measurements at all timepoints in study between baseline and 6 months post-randomization. Intended for evaluation of efficacy of metformin versus placebo.