Influence of Aliskiren on Proteinuria (ALIPRES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01219413
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : September 24, 2015
Information provided by (Responsible Party):
Leszek Tylicki, Medical University of Gdansk

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Proteinuria Blood Pressure Drug: Aliskiren, Perindopril Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Aliskiren on Proteinuria in Chronic Nondiabetic Kidney Disease: a Double Blind Cross-over Randomized Controlled Trial
Study Start Date : March 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: aliskiren, placebo, perindopril Drug: Aliskiren, Perindopril
Rasilez 300 mg Prestarium 10 mg
Other Names:
  • Rasilez 300 mg
  • Prestarium 10 mg

Experimental: perindopril, placebo, aliskiren Drug: Aliskiren, Perindopril
Rasilez 300 mg Prestarium 10 mg
Other Names:
  • Rasilez 300 mg
  • Prestarium 10 mg

Primary Outcome Measures :
  1. 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 [ Time Frame: march 2014 - april 2014 ]

Secondary Outcome Measures :
  1. reduction of blood pressure [ Time Frame: march 2013 - april 2014 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01219413

Medical University of Gdansk
Gdansk, Pomorskie, Poland, 80-211
Sponsors and Collaborators
Medical University of Gdansk

Responsible Party: Leszek Tylicki, Prof., Medical University of Gdansk Identifier: NCT01219413     History of Changes
Other Study ID Numbers: ST-4/Aliskiren/01
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by Leszek Tylicki, Medical University of Gdansk:
renin inhibitor
chronic kidney diseases
ACE inhibitor

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Urination Disorders
Urological Manifestations
Signs and Symptoms
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents