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Albuminuria as surrogate endpoint in clinical trials

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Title:   Albuminuria as surrogate endpoint in clinical trials
Investigator:  Tobias Kropelin
Supervisor:  Hiddo Lambers Heerspink, 
Promotor:  Dick de Zeeuw
Summary:   The presence of small amounts of albumin in the urine is one of the earliest signs of kidney damage and heralds a poor prognosis for renal and cardiovascular disease. Since albuminuria is such an important indicator of future renal and cardiovascular events, there is increased interest to test the effects of novel drugs on albuminuria. The rationale is that when one lowers albuminuria in the short-term one will provide long-term renal (and cardiovascular protection). Indeed previous studies have used albuminuria as a surrogate endpoint to replace hard renal and cardiovascular endpoints (such as dialysis or CV-death). However, there is persistent uncertainty how to optimally use albuminuria as surrogate endpoint in clinical drug trials. For example it is unknown how often urine for albuminuria assessment should be collected. The aim of this PhD project is to conduct a series of empirical studies to optimize the use of albuminuria as a surrogate for hard renal endpoints in nephrology and cardiovascular trials 
Financing:  UMCG 
Start:  01-09-2012 
End: 01-09-2015
     
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