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Dual RAS-blockade by ACE-inhibition and AT1 receptor blockade, role of the ACE I/D genotype and low sodium diet in non-diabetic proteinuric patients.

Dual RAS-blockade by ACE-inhibition and AT1 receptor blockade, role of the ACE I/D genotype and low sodium diet in non-diabetic proteinuric patients- a double blind randomised, plcebo controlled cross-over trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23057
Enrollment
56
Registered
2006-05-05
Start date
2006-04-28
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

non-diabetic proteinuria

Interventions

Lisinopril 40 mg, with the addition of valsartan 320 mg (160 mg 1dd2) or placebo, both during low dietary sodium intake and high dietary sodium intake in randomised order.

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age older than 18 year; 2. Chronic non-diabetic renal disease, as established by history, urine analysis, serum biochemistry tests and/or renal biopsy; 3. Creatinine clearance > 30 ml/min/1.73 m; 4. Residual proteinuria > 1 g/24h.

Exclusion criteria

Exclusion criteria: 1. Failure to comply with the above inclusion criteria; 2. Diabetes mellitus; 3. Any contra-indication against the use of ACE inhibitors or AT1 receptor blockers; 4. A history of myocardial infarction, unstable angina, coronary by-pass or CVA during the past 6 months; 5. Heart failure NYHA class III-IV; 6. High rate of renal function loss (decline in creatinine clearance > 6 ml/min/1.73m2 during the previous year); 7. Need for treatment with corticosteroids, NSAID’s or immunosuppressive drugs; 8. Proteinuria > 10 g/24h and hypoalbuminaemia 100 mmHg); 10. Serum potassium > 6 mmol/L.

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be reduction of proteinuria and blood pressure expressed as percentage change from baseline and analysed with each patient as his or her own control.

Secondary

MeasureTime frame
1. Serum creatinine; 2. Circulating RAS parameters; 3. Lipid profile; 4. Adiponectin.

Contacts

Public ContactF. Waanders

University Medical Center Groningen (UMCG), Department of Nephrology, Hanzeplein 1

F.Waanders@int.umcg.nl+31 (0)50 3611564

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)