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Optimal hard endpoints in clinical trials of renal disease progression

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Title :   Optimal hard endpoints in clinical trials of renal disease progression
Investigator:  M Weldegiorgis 
Supervisor:  HJ Lambers Heerspink 
Promotor:  D. de Zeeuw 
Summary: 

Long-term hard outcome trials are conducted to register novel drugs. Studies should use meaningful clinical endpoints to most reliably assess the clinical impact and tolerability of a new intervention. Current composite endpoints employed in nephrology trials are doubling of serum creatinine, ESRD, or death. Although each component of the composite endpoint is well accepted, the validity of each component is hampered by various factors.

  • A doubling of serum creatinine is not a “hard” endpoint but reflects biomarker changes.
  • The onset of ESRD is not well defined but is based on the judgment of the clinician.
  • Death may be unrelated to renal cause and therefore inclusion of death in a composite endpoint can dilute the expected treatment effect.

 

Taken together, each component of currently employed endpoints in nephrology trials (although well accepted) has its limitations and it appears that no proper well defined clinical trial endpoint exists. The aim of this project is to conduct a series of empirical analyses to define the most optimal renal endpoint in nephrology trials.

Financing:  UMCG
Start:  1-3-2012
End: 1-3-2015
    
Projects
The use of a multiple parameter response efficacy score to predict the effect of a drug on hard renal and cardiovascular
Diabetes Mellitus Treatment for Renal Insufficiency Consortium (DIAMETRIC) database 
System biology approach for discovery of biomarkers of renal disease progressioni in diabetes (SysKid)
PROVALID – prospective multinational cohort study in patients with type 2 diabetes treated in primary care
Vitamin-D deficiency as a risk marker for renal and CV complications in the general population
A novel approach of personalized medicine: considering multiple effects of a single drug
Optimal hard endpoints in clinical trials of renal disease progression
Albuminuria as surrogate endpoint in clinical trials
Individual therapy response to a sodium-glucose transport inhibitor
Involving patients in the assessment and evaluation of medication treatment
Groningen Initiative to Analyse Type-2 diabetes Treatment ( GIANTT )
The role of medication adherence in predicting treatment response and estimating cost-effectiveness of statin treatment
Pharmacogenetics and response to treatment of oral antidiabetics
Quality of prescribing: patient specific indicators that predict better outcomes in diabetes patients
Quality assessment of pharmacotherapy in patients with chronic kidney disease
Cost effectiveness of ACEi and ARBs on renal failure in diabetes patients
Drug information and risk communication in Africa
Regulatory Science Projects