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Drugs and kidney function in the older age group

Drug handling in the older age group: The impact of renal tubular function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12611000035921
Enrollment
60
Registered
2011-01-11
Start date
2011-04-05
Completion date
2011-05-24
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The kidney plays a major role in the handling of most drugs by several mechanisms including filtration and tubular secretion / reabsorption. With renal impairment, modification of drug doses is required. In clinical practise, changes in renal function are estimated according to the creatinine clearance (CrCl) (estimate of glomerular filtration rate [GFR]). The formulae used, include age as a variable that assumes that renal function declines with age alone. It is also assumed that changes in tubular function parallel changes in GFR , but this may not be correct. Given that many drugs are organic acids, tubular secretion / reabsorption are important variables that in the setting of impaired kidney function may significantly alter drug handling. Previous studies have shown that a simple drug cocktail given simultaneously to measure tubular secretion and reabsorption is both safe and representative of tubular function in younger subjects. Using this method, we will compare a normal (normal plasma creatinine, no known medical conditions) older age group (aged >65) with a matched aged group with mild renal impairment (eGFR < 60 ml/min) as well as a younger normal group (20 -40 yrs). A more accurate estimate of the contribution of renal tubular function for drug handling will allow safer drug prescribing especially in the elderly patients.

Interventions

A simple one off administration of a drug cocktail (fluconazole 50mg single oral dose, pindolol 15mg single oral dose, para-aminohippurate 440 mg iv over 1 minute ) given simultaneously to measure tubular secretion and reabsorption is both safe and representative of tubular function. GFR will be measured using standard radioisotope (chromium) labelled EDTA clearance. Using these methods, we will compare a normal (normal plasma creatinine, no known medical conditions) older age group (aged >65) w

A simple one off administration of a drug cocktail (fluconazole 50mg single oral dose, pindolol 15mg single oral dose, para-aminohippurate 440 mg iv over 1 minute ) given simultaneously to measure tubular secretion and reabsorption is both safe and representative of tubular function. GFR will be measured using standard radioisotope (chromium) labelled EDTA clearance. Using these methods, we will compare a normal (normal plasma creatinine, no known medical conditions) older age group (aged >65) with a matched aged group with mild renal impairment (eGFR < 60 ml/min) as well as a younger normal group (20 -40 yrs). A more accurate estimate of the contribution of renal tubular function for drug handling will allow safer drug prescribing especially in the elderly patients. Participants will be recruited over a 6 month period.

Sponsors

University of Otago
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Group 1. Normal individuals aged > 65 years with a normal plasma creatinine and calculated creatinine clearance > 60 ml/min. Group 2. Individuals aged > 65 years with evidence of mild renal impairment (Stage 3 CKD GFR 35 -60ml/min). Group 3. A younger normal cohort aged 30 – 50 for comparison with group 1.

Exclusion criteria

Exclusion criteria. Not able to give consent. Impaired renal function < than 35 ml/min.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026