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Guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency

We have adopted this International Scientific Guideline - EMA/CHMP/500825/2016 

Last updated

About this guideline

 Adopted by the TGA: 28 February 2020

Overseas effective date: 1 April 2017

Categories: Clinical efficacy and safety | Genitoruinary system and sex hormones
 

TGA annotations

Indigenous Australians experience a high rate of renal disease. Ideally, these should be included in clinical trials or a clinical trial in this group should be considered in the post market setting.

Many different terms are used to describe renal impairment, renal injury, renal failure. These terms should be clearly defined.

Where biomarkers are used - e.g. creatinine, urine albumin excretion, cystatin C - the value of these measures in the prediction of development of renal impairment should be included.

Outcomes should include need for renal replacement therapy or transplant.

Different centres may have different protocols for the management of CRF, thus clinical studies should include a protocol shared between sites, or results adjusted for potential differences in study centres.

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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For more information see International scientific guidelines adopted in Australia.

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