Diabetic Nephropathy Type 2 Clinical Trial
Official title:
Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation: A Rotation Study of Different Albuminuria Lowering Drug Classes to Study Individual Drug Response in Diabetes
This project is an intervention study where type 2 diabetic patients will rotate through 4 different albuminuria lowering drugs with the aim to 1) quantify the individual relationship between drug exposure and albumin lowering response of different albuminuria lowering drugs in type 1 and type 2 diabetics; and 2) to investigate the effect of the same drug intervention on the glycocalyx layer in blood vessels. The overall purpose of this study is to allow for future personalized treatment of diabetics with regards to treating kidney disease more effectively than current standardized strategies.
Standard treatment to patients with diabetes and persistent albuminuria nowadays are drugs
inhibiting the RAAS-system as these thus assert renoprotective effects. It has been shown,
that many patients do not respond to these, which means that many remain at a high renal and
cardiovascular risk and highlights the need to understand the drug response variability and
to find alternative albuminuria lowering treatments in order to optimize treatment for each
individual.
Various drugs other than RAAS-inhibitors are available, that also decreases albuminuria.
However, whether individual patients not responding to these beneficially respond to other
albuminuria lowering drugs has not been prospectively investigated. Therefore a better
understanding on the individual response to different albuminuria lowering drugs, of which
some are developed for another indication, may help to tailor optimal therapy.
This study is designed as a randomized multicenter crossover trial with a total duration of
48 weeks and with a total of 52 patients diagnosed with type 2 diabetes, as well as elevated
albuminuria (UACR between 50 mg/g and 500 mg/g).
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