Influence of Aliskiren on Proteinuria (ALIPRES)

This study has been completed.
Sponsor:
Information provided by:
Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT01219413
First received: October 12, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Proteinuria
Blood Pressure
Drug: Aliskiren, Perindopril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduction of blood pressure [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: March 2009
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219413

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

No publications provided

Responsible Party: Professor Boleslaw Rutkowski, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01219413     History of Changes
Other Study ID Numbers: ST-4/Aliskiren/01
Study First Received: October 12, 2010
Last Updated: October 12, 2010
Health Authority: Poland: Ethics Committee
Poland: Ministry of Health

Keywords provided by Medical University of Gdansk:
aliskiren
renin inhibitor
proteinuria
chronic kidney diseases
ACE inhibitor

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

ClinicalTrials.gov processed this record on October 21, 2014