ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000035921

Ethics application status

Approved

Date submitted

3/01/2011

Date registered

11/01/2011

Date last updated

15/04/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

Drugs and kidney function in the older age group

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Analysis of renal tubular function with respect to drug handling in individuals aged >65 years ?

Condition category

Condition code

Renal and Urogenital

Kidney disease

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

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.

Intervention code [1]

Not applicable

Comparator / control treatment

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).

Control group

Active

Outcomes

Primary outcome [1]

In clinical practice it is assumed that changes in tubular function parallel changes in GFR. However this may be incorrect.
As most drugs are organic acids, renal tubular handling may play a critical role in the elimination of drugs.
Clearance of these drugs will be determined by analysis of area under receiver operated curves (ROC) and correlated to the GFR clearances.

Timepoint [1]

Blood samples wlll be collected at time 0, and 1hr,2hr,4hr,6hr, 24hr post drug administration and timed urine samples (0-3hr, 3-6hr, 6-24hr) will be collected for each participant. The samples will be stored and analysed as a single batch at the completion of the study.

Secondary outcome [1]

Nil

Timepoint [1]

nil

Eligibility

Key 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.

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

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

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2011

Actual

5/04/2011

Date of last participant enrolment

Anticipated

Actual

24/05/2011

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Otago Medical Research Foundation

Address [1]

C/o University of Otago
PO Box 56
Dunedin 9054

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

C/o University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Y Regional Ethics Committee

Ethics committee address [1]

3rd floor, BNZ building 
354 Victoria St
PO Box 1031
Hamilton 3240

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

24/12/2010

Ethics approval number [1]

NTY/10/12/2103

Summary

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.

Trial website

Nil

Trial related presentations / publications

Nil

Public notes

Contacts

Principal investigator

Name

Prof Robert Walker

Address

Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
NZ

Country

New Zealand

Phone

6434740999

Fax

6434747641

rob.walker@otago.ac.nz

Contact person for public queries

Name

Prof Robert Walker

Address

Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin. 9054

Country

New Zealand

Phone

+64 3 4740999 Ex 8045

Fax

+ 64 3 474 7641

rob.walker@otago.ac.nz

Contact person for scientific queries

Name

Prof Robert Walker

Address

Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin. 9054

Country

New Zealand

Phone

+64 3 4740999 Ex 8045

Fax

+ 64 3 474 7641

rob.walker@otago.ac.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A Population Pharmacokinetic Model for 51Cr EDTA to Estimate Renal Function.	2017	https://dx.doi.org/10.1007/s40262-016-0489-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically