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Microalbuminuria: target for renoprotective therapy PRO
Sara S Roscioni1, Hiddo J Lambers Heerspink1, Dick de Zeeuw1
1Department of Clinical Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Kidney International
|April 25, 2014
Summary
Microalbuminuria is a valid surrogate marker for chronic kidney disease progression. Using it in clinical trials can accelerate drug development and reduce trial costs, benefiting patients sooner.
Area of Science:
- Nephrology
- Clinical Trials
- Pharmacology
Background:
- Clinically meaningful outcomes for chronic kidney disease (CKD) progression, such as end-stage renal disease, require long study durations.
- Surrogate endpoints can potentially shorten follow-up times, reduce sample sizes, and facilitate trials in earlier disease stages.
Purpose of the Study:
- To review evidence supporting microalbuminuria as a valid surrogate endpoint in CKD clinical trials.
- To assess the association of albuminuria with renal prognosis and treatment effects.
Main Methods:
- Review of recent data on microalbuminuria as a surrogate endpoint.
- Analysis of studies linking albuminuria to renal prognosis and treatment outcomes.
- Examination of albumin's direct role in kidney cell function and pathogenesis.
Main Results:
- Albuminuria is associated with poorer renal prognosis.
- Treatments reducing albuminuria levels delay CKD progression and clinical outcomes.
- Emerging evidence suggests albumin has a direct pathogenic role in kidney disease.
Conclusions:
- Microalbuminuria is a valid surrogate marker for renal outcomes in CKD.
- Adoption of microalbuminuria as a surrogate endpoint can decrease trial costs and accelerate drug development.
- This facilitates earlier patient access to novel CKD therapies.
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