proteinuria and hypertension MedDRA version: 9.1 Level: LLT Classification code 10037032 Term: Proteinuria
Conditions
Interventions
Trade Name: Ramil
Product Name: ramipril
Product Code: 58/257/03-C
Pharmaceutical Form: Tablet
INN or Proposed INN: ramipril
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
University Hospital Motol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients up to 18 years at least 6 months after renal transplantation with functional graft and persistent proteinuria >200mg/m2/day (on 2 consecutive occasions at least 1 month apart) not being treated with ACE-inhibitors. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: stenosis of graft artery, acute rejection < 3 months before study entry, severe chronic allograft nephropathy with severely reduced glomerular filtration rate (estimated creatinine clearance <30 ml/min/1.73m2), patients with hypotension, patients with a history of allergic or other adverse effects of ACE-inhibitors, pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy and safety of ACE-inhibitor in the lowering of proteinuria in patients after renal transplantation.;Secondary Objective: to investigate whether ACE-inhibitor can improve control of arterial hypertension in transplanted patients, to investigate whether ACE-inhibitor can produce a regression of left ventricular hypertrophy. ;Primary end point(s): Reduction of proteinuria in patients after renal transplantation. | — |
Countries
Czech Republic
Outcome results
None listed