Albuminuria in non-diabetic nephropathy patients MedDRA version: 12.1 Level: LLT Classification code 10001580 Term: Albuminuria
Conditions
Interventions
Trade Name: Rasilez
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Aliskiren
CAS Number: 173334-57-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female outpatients 18 to 70 years (inclusive) of age included. 2. Non-diabetic renal disease as established by history, urine analysis, serum biochemistry tests and/or renal biopsy with residual albuminuria by UAER of >300 mg/24 hrs from 24 hour urine collection during conventional RAAS-blockade of at least 8 weeks of ACE-inhibition or ARB treatment at the maximum recommended dose. 3. Glomerular Filtration Rate (GFR) >30 ml/min/1.73m2 as determined by creatinine clearance 4. Patients with a history of hypertension and msSBP of =160 mm Hg and msDBP =105 mm Hg at screening and baseline. 5. Female subjects of child bearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), for at least three (3) months prior to first dosing and for the entire duration of the study, through study completion and for 30 days following study completion. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to screening. Menopause will be confirmed by a FSH level determined by the reference range used by the local clinical laboratory at screening. Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to screening. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. 6. Patient must have a body mass index (BMI) within the range of 18 to 35 kg/m2. 7. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previously treated (within 3 months of screening) with aliskiren or a combination of aliskiren and ramipril. 2. Renovascular hypertension or severe hypertension (msDBP >105 mmHg and msSBP >160 mmHg) 3. Pregnant or nursing (lactating) women, where pregnancy is defined as a state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/ml). 4. A medical history of instable coronary artery disease, myocardial infarction, coronary bypass surgery or cerebrovascular accident within the last six (6) months 5. Diabetes mellitus (Type 1 and Type 2) 6. Heart failure NYHA class III-IV 7. High rate of renal function loss (decline in creatinine clearance >6 ml/min/1.73m2 during the previous year or 1.5 ml/min/1.73m2 per month) 8. If subject is currently using and expected to continue or start any medication listed in Section 6.6.5 concomitant medication. 9. Albuminuria >3 g/24h and/ or hypoalbuminaemia 5.3 mmol/L For the full list of exclusion criteria, please refer to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To investigate the added effects of 300 mg aliskiren on albuminuria in patients with non-diabetic nephropathy treated with ramipril 10 mg and volume intervention. ;Primary end point(s): Change in albuminuria.;Secondary Objective: • To investigate the added effect of volume intervention on albuminuria in non-diabetic nephropathy patients treated with ramipril 10 mg and aliskiren 300 mg • To investigate the effects of volume intervention on albuminuria in non-diabetic nephropathy patients treated with ramipril 10 mg • To investigate the effects of 300 mg aliskiren added to ramipril 10 mg and volume intervention on RAAS biomarkers, in non-diabetic nephropathy patients • To investigate the effects of 300 mg aliskiren added to ramipril 10 mg and volume intervention on renal function (GFR/hemodynamic measurements) in non-diabetic nephropathy patients • To investigate the effects of 300 mg aliskiren added to ramipril 10 mg and volume intervention on blood pressure in non-diabetic nephropathy patients • To investigate the safety and tolerability of aliskiren 300 mg added to ramipril 10 mg and volume intervention in non-diabetic nephropathy patients. | — |
Countries
Netherlands
Outcome results
None listed