Olmesartan, Oxidant Stress and in Vivo Re-Endothelialization Capacity of Endothelial Progenitor Cells from Patients with Chronic Kidney Disease (OECD Study) - OECD Study
- Conditions
- We will investigate the effect of Olmesartan Medoxomil 40 mg on the reendothelialization capacity of Endothelial Progenitor Cells in patients with chronic kidney disease. In this clinical setting Olmesartan Medoxomil is expected to have tissue protective effeects.
- Registration Number
- EUCTR2008-003249-10-DE
- Lead Sponsor
- niversity of the Saarland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
* Signed written informed consent
* Woman or man aged 18 to 70 years
* Chronic Kidney Disease (CKD II-IV)
* Endogenous creatinine clearance between 15 ml/min and 90 ml/min. No impending need for dialysis during the study
* HbA1C <8% for patients with diabetes mellitus type II
* No Autosomal Dominant Polyzystic Kidney Disesase (ADPKD)
* No known metabolic diease except diabetes mellitus type II
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
* Myelodysplastic or –proliferative diseases
* Malignant disease diagnosed within the last 5 years
* Renal anemia (Hb =10,5 g/dl for men or =10 g/dl for women) or therapy with rHuEPO or analogs
* Therapy with growth factors, e.g. GM-CSF or VEGF
* Statin Therapy
* Bleeding episodes relevant for Hb within the last 3 months or known gastrointestinal bleeding sources
* Foreseeable need for dialysis
* Sitting dBP >100 mmHg with standard antihypertensives (incl. ACE Inhibitors or ARB)
* Sitting sBP >100 mmHg with standard antihypertensives (incl. ACE Inhibitors or ARB)
* Known intolerance of ARBs, e.g. Olmetec®, Diovan®, Lorzaar®, Atacand®, Aprovel®, Mircardis®, Teveten®
* Known HIV infection
* Systemic chemotherapy or radiotherapy
* Chronic infection and/or CRP >10 mg/l at the beginning of the study
* Acute cardiovascular episodes
* Organ transplants
* Pregnant or lactating woman
* Woman of childbearing potential without adequate contraception
* Psychiatric disease or chronic cerebral attacks
* Non-compliance or participation in another clinical study within the last 30 days
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method