Influence of Aliskiren on Proteinuria

NCT01219413 | Completed Phase 4 DMC

• 1 other identifier: ST-4/Aliskiren/01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Proteinuria; Blood Pressure

Keywords

aliskiren; renin inhibitor; proteinuria; chronic kidney diseases; ACE inhibitor

Outcome Measures

Primary Outcomes (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

  march 2014 - april 2014

Secondary Outcomes (1)

• reduction of blood pressure

  march 2013 - april 2014

Study Arms (2)

aliskiren, placebo, perindopril

EXPERIMENTAL

Drug: Aliskiren, Perindopril

perindopril, placebo, aliskiren

EXPERIMENTAL

Drug: Aliskiren, Perindopril

Interventions

Aliskiren, Perindopril DRUG

Rasilez 300 mg Prestarium 10 mg

Also known as: Rasilez 300 mg, Prestarium 10 mg

aliskiren, placebo, perindopril; perindopril, placebo, aliskiren

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, 80-211, Poland

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria

Interventions

aliskiren; Perindopril

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 13, 2010
• Study Start: March 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

PL (1)