The renal handling of metformin in the setting of impaired kidney functio

Phase 4

• Conditions: renal disease; type 2 diabetes; Renal and Urogenital - Kidney disease; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12614001180606
• Lead Sponsor: Dr Dan Wright

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Subjects with a measured eGFR either <=30mL/min, between >30 & <= 60mL/min and > 60 mL/min
2. Subjects who are >18 years of age.

Exclusion Criteria

1.Subjects who are unable or unwilling to give written informed consent
2.Subjects with Type 2 diabetes or who are currently taking metformin
3.Subjects with evidence of >25% change in eGFR in the past month
4.Significant asthma, heart failure or any condition associated with a fragile fluid balance (potential reaction to beta-blockade)
5.Pregnancy
6.Known allergy to medication classes; biguanides or aminoglycosides.
7.The concomitant use of drugs known or suspected to interact with the tubular transport of metformin or creatinine including: antibiotics (unless a 2 week washout), beta-blockers, calcium channel blockers, antiarrhythmic drugs, H2 blockers, thiazide diuretics (unless a 7 day washout), antituberculosis drugs, and probenecid.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
metformin renal clearance - assessed by the measurement and analysis of plasma and urine concentrations of metformin (note that both plasma and urine concentrations are needed to assess this primary outcome)[Plasma concentrations measured post-dose at 15-30 minutes, 30-60 minutes, 90-120 minutes, 4, 6, 8 and 24 hours.<br>Timed urine concentrations measured at 0-3, 3–6, 6–24 hours.]

Secondary Outcome Measures

Name	Time	Method
Gentamicin clearance (a marker for GFR) - assessed by the measurement and analysis of plasma concentrations of gentamicin[Plasma concentrations measured post-dose at 15-30 minutes, 30-60 minutes, 90-120 minutes, 4, 6, 8 and 24 hours.];Creatinine clearance (the gold standard for assessing kidney function clinically) - assessed by the measurement and analysis of plasma and urine concentration of creatinine[Plasma concentrations measured post-dose at 15-30 minutes, 30-60 minutes, 90-120 minutes, 4, 6, 8 and 24 hours.<br>Timed urine concentrations measured at 0-3, 3–6, 6–24 hours.];urate renal clearance - assessed by the measurement and analysis of urate plasma and urine concentrations[Plasma concentrations measured post-dose at 15-30 minutes, 30-60 minutes, 90-120 minutes, 4, 6, 8 and 24 hours.<br>Timed urine concentrations measured at 0-3, 3–6, 6–24 hours.]