A rotation study of different albuminuria lowering drug classes to study individual drug response in diabetes

Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation (ROTATE-2)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001977-18-DK

Enrollment

Unknown

Registered

2017-05-08

Start date

2017-09-26

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes and albuminuria MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Trade Name: Micardis Pharmaceutical Form: INN or Proposed INN: TELMISARTAN CAS Number: 144701-48-4 Trade Name: Jardiance Pharmaceutical Form: INN or Proposed INN: EMPAGLIFLOZIN CAS Number: 864070-4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Type 2 diabetes • eGFR > 45ml/min/1.73m2 • Albumin:creatinine ratio >50mg/g and =500 mg/g • Age = 18 years • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Pregnant women and women of child-bearing potential who are not using reliable contraception • Cardiovascular disease: myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) 160/100 mmHg) • Active malignancy • History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension)

Design outcomes

Primary

Measure	Time frame
Main Objective: A better understanding on the individual response to different albuminuria lowering drugs and a better understanding why these drugs, of which some are developed for another indication may help to tailor optimal therapy. Therefore in this study individual patients will be subjected to four different drug classes that have all been shown to reduce albuminuria on a group level. The drug that induces the strongest albuminuria-lowering response within an individual patient will be repeated in a fifth treatment period to assess whether the albuminuria lowering effect can be confirmed in a second treatment period to ascertain the consistency of the individual response;Secondary Objective: The secondary objective of this study is to investigate the effect of different albuminuria lowering interventions on the glycocalyx. It has been shown that the glycocalyx plays an important role in the pathogenesis of diabetic kidney disease. The glycocalyx is a gel-like structure which is composed of protein-cores connected to heparan sulfate and chondroitin sulfate side-chains. The glycocalyx covers the endothelium and because of its negative charge forms an important barrier against albumin filtration. It has been shown that the glycocalyx dimension is significantly smaller in patients with type 1 diabetes compared to healthy controls. Treatment with albuminuria-lowering drugs may assert their beneficial effect through restoring perturbations in the glycocalyx. We therefore aim to measure the thickness of the glycocalyx during treatment with each of the four drug classes and correlate this to the albuminuria-lowering response within each individual patient.;Primary end point(s): Reduction in albuminuria;Timepoint(s) of evaluation of this end point: after 4 weeks of treatment	—

Measure

Time frame

Main Objective: A better understanding on the individual response to different albuminuria lowering drugs and a better understanding why these drugs, of which some are developed for another indication may help to tailor optimal therapy. Therefore in this study individual patients will be subjected to four different drug classes that have all been shown to reduce albuminuria on a group level. The drug that induces the strongest albuminuria-lowering response within an individual patient will be repeated in a fifth treatment period to assess whether the albuminuria lowering effect can be confirmed in a second treatment period to ascertain the consistency of the individual response;Secondary Objective: The secondary objective of this study is to investigate the effect of different albuminuria lowering interventions on the glycocalyx. It has been shown that the glycocalyx plays an important role in the pathogenesis of diabetic kidney disease. The glycocalyx is a gel-like structure which is composed of protein-cores connected to heparan sulfate and chondroitin sulfate side-chains. The glycocalyx covers the endothelium and because of its negative charge forms an important barrier against albumin filtration. It has been shown that the glycocalyx dimension is significantly smaller in patients with type 1 diabetes compared to healthy controls. Treatment with albuminuria-lowering drugs may assert their beneficial effect through restoring perturbations in the glycocalyx. We therefore aim to measure the thickness of the glycocalyx during treatment with each of the four drug classes and correlate this to the albuminuria-lowering response within each individual patient.;Primary end point(s): Reduction in albuminuria;Timepoint(s) of evaluation of this end point: after 4 weeks of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Glycocalyx thickness;Timepoint(s) of evaluation of this end point: After 4 weeks of treatment	—

Countries

Denmark

Contacts

Public ContactHiddo Lambers-Heerspink

University Medical Center Groningen

h.j.lambers.heerspink@umcg.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026