Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation (ROTATE-2) (ROTATE-2)
|ClinicalTrials.gov Identifier: NCT03504566|
Recruitment Status : Withdrawn (Registered and published incorrectly)
First Posted : April 20, 2018
Last Update Posted : September 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathy Type 2||Drug: Linagliptin Drug: Empagliflozin Drug: Telmisartan Drug: Sulodexide||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 15, 2017|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 1, 2019|
All patients recieve, in randomomized order a four way treatment schedule. Due to the nature of the study, the individual patient will serve as his/hers own comparator.
- Strongest albuminuria-lowering effect. [ Time Frame: 48 weeks ]Proportion of patients in whom the drug selected in the fifth treatment period exerts the strongest albuminuria lowering effect as compared to the other drugs used during the treatment periods.
- Correlation of albuminuria-lowering response. [ Time Frame: 48 weeks ]The first secondary outcome is the degree of correlation in albuminuria-lowering responses between drugs within individual patients during the four treatment periods.
- Effect on glycocalyx. [ Time Frame: 48 weeks ]The second secondary outcome is the effect of the four drugs on the glycocalyx.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504566
|Steno Diabetes Center Copenhagen|
|Gentofte, Denmark, 2820|