Influence of Aliskiren on Proteinuria

Chronic Kidney Disease Clinical Trial

— ALIPRES  

Official title:

The Effect of Aliskiren on Proteinuria in Chronic Nondiabetic Kidney Disease: a Double Blind Cross-over Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219413
• Other study ID #: ST-4/Aliskiren/01
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2010
• Last updated: September 23, 2015
• Start date: March 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2015
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics CommitteePoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To evaluate the proteinuria lowering efficacy as well as tolerability and safety of the renin inhibitor aliskiren compared with that of placebo and angiotensin converting enzyme inhibitor perindopril in patients with non-diabetic chronic renal disease.

Description:

Proteinuria is a major risk factor for progression to end-stage renal disease in both diabetic and nondiabetic nephropathies. Angiotensin II and aldosterone are the key players in the development of renal failure, either directly by promoting tissue fibrosis or indirectly through their action on glomerular hemodynamic and proteinuria. Therefore, pharmacological inhibition of the renin-angiotensin-aldosterone system (RAAS) may have a beneficial impact on proteinuria and chronic kidney diseases progression. Recently, renin inhibitors, a new class of drugs that selectively inhibits angiotensin II formation at the first step of the RAAS cascade has been introduced to clinical practice. Aliskiren is the first orally bioavailable direct renin inhibitor approved for the treatment of hypertension. Blood pressure (BP)-lowering effect of aliskiren is associated with a decreased generation of angiotensin I, as it blocks its generation from angiotensinogen, by inhibiting the active enzymatic site of renin. The investigators plan this study to evaluate the short-term effects of treatment with aliskiren to those of placebo and ACEI perindopril on proteinuria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65 years

• chronic non-diabetic proteinuric nephropathy

• creatinine clearance above 30 ml/min

• stable proteinuria above 500 mg/ 24 hours

• blood pressure above 125/75 mmHg and below 150/95 mmHg

• no steroids or other immunosuppressive treatment for a minimum of six months before the study

Exclusion Criteria:

• unstable coronary heart disease

• decompensated congestive heart failure in the previous 6 months

• episode of malignant hypertension or stroke in the history

• diabetes

• creatinine clearance below 30 ml/min

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure
• Chronic Kidney Disease
• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

Drug:
• Aliskiren, Perindopril
Rasilez 300 mg Prestarium 10 mg

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the antiproteinuric effect of adding aldosterone antagonist, spironolactone to the combination therapy with angiotensin converting enzyme inhibitor and AT-1 receptor blocker in maximal recommended doses. reduction of proteinuria		march 2014 - april 2014	No
Secondary	reduction of blood pressure		march 2013 - april 2014	Yes