Trial · NCT06090227
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Slope of urinary NPHS2:Creatinine ratio | 6 months following randomization | Measure of podocinuria via evaluation of urine podocin mRNA(nphs2) (measured as number of molecules detected by qPCR in the collected urine pellet) over the creatinine concentration. Intended for evaluation of efficacy of metformin versus placebo. |
| Secondary | estimated Glomerular Filtration Rate (eGFR) | 6 months post-randomization | Calculated from serum creatinine (mg/dl) using the CKD-EPI formula. Intended for evaluation of efficacy of metformin versus placebo. |
| Secondary | Slope of eGFR | 6 months post-randomization | 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. |
| Secondary | Urine protein:creatinine ratio | 6 months post-randomization | Calculated ratio of urine protein and creatinine, each collected from the electronic medical record. Intended for evaluation of clinical efficacy of metformin versus placebo. |
| Secondary | Slope of urine protein:creatinine ratio | 6 months post-randomization | 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. |
| Secondary | Complete remission | 6 months post-randomization | 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. |
| Secondary | Complete or partial remission | 6 months post-randomization | 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. |
| Secondary | Discontinuation of study drug | Within 6 months post-randomization | Number of patients who discontinued study drug for any reason within 6 months of randomization. Intended for evaluation of patient compliance of metformin use. |
| Secondary | Modified Kidney Disease Quality of Life (KDQOL) score | 1 month post-randomization | 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. |
| Secondary | Modified Kidney Disease Quality of Life (KDQOL) score | 6 months post-randomization | 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. |
| Secondary | Hypoglycemia symptom scores | 6 months post-randomization | 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. |
| Secondary | Gastrointenstinal symptom scores | 1 month post-randomization | 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. |
| Secondary | Gastrointenstinal symptom scores | 6 months post-randomization | 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. |
| Secondary | Kidney biopsy fibrosis scores | 6 months post-randomization | 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. |
| Secondary | Number of patients with Lactate levels>2.5 | Within 6 months post-randomization | As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo. |
| Secondary | Number of patients with Lactate levels>5 | Within 6 months post-randomization | As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo. |
| Secondary | Number of patients with Vitamin B12 levels <lower limit of Normal | Within 6 months post-randomization | As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo. |
| Secondary | Number of patients with serum glutamic-oxaloacetic transaminase (SGOT) >2 fold increase | Within 6 months post-randomization | As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo. |
| Secondary | Number of patients with Serum Glutamic Pyruvic Transaminase (SGPT) >2 fold increase | Within 6 months post-randomization | As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo. |
| Secondary | Number of patients with Serum amyloid P component (SAP) >2 fold increase | Within 6 months post-randomization | As determined from the electronic medical record. Intended for evaluation of adverse effects of metformin versus placebo. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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