A phase IIa study to characterize the effects of CCL2 inhibition with the Spiegelmer® NOX-E36 in patients with type 2 diabetes mellitus and albuminuria.

OXXON Pharma AG0 sites75 target enrollmentJanuary 30, 2012

Overview

No summary available.

Registry

who.int

Start Date

January 30, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

OXXON Pharma AG

•1\) Type 2 diabetes mellitus according to American Diabetes Association (ADA) definition
•2\) Age \= 18
•3\) HbA1c between 6\.0% and 10\.5%, inclusive
•4\) ACR \> 100 mg/g calculated 3 times in first morning void urine, at least 2 of the measurements \> 100 mg/g
•5\) Patients on stable (unchanged medication for at least 3 months) treatment to control hypertension, hyperglycemia and (if applicable) dyslipidemia
•6\) Stable treatment with angiotensin\-converting enzyme inhibitors (ACEi) and/or Angiotensin II receptor blockers (ARBs) (renin\-angiotensin system \[RAS] blockade)
•7\) Willing and able to understand and sign an approved Informed Consent form
•8\) Men must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment. Women must be of non\-childbearing potential
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\) Type 1 diabetes mellitus
•2\) eGFR \=25 mL/min/1\.73m2 (calculated by Chronic Kidney Disease Epidemiology Collaboration \[CKD\-EPI] formula)
•3\) Recent cardiovascular events (3 months)
•4\) Uncontrolled hypertension (upper limits 180/110 mmHg)
•5\) Dialysis and/or acute kidney injury within 3 months before screening
•6\) Significant edema, infectious diseases, leg ulcers
•7\) Severe concurrent disease which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study
•8\) Treatment with any other investigational agent, or participation in another clinical study within 90 days prior to baseline visit
•9\) Patient with known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
•10\) In the judgment of the clinical investigator, clinically significant abnormal laboratory values at the screening visit