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Effect of RAS Blockers on Chronic Kidney Disease Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01)

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ClinicalTrials.gov Identifier: NCT03195023
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Maria Angeles Goicoechea Diezhandino, Hospital General Universitario Gregorio Marañon

Brief Summary:
This study evaluates the effect of renin-angiotensin blockers on chronic kidney disease progression in elderly (>65 years old) patients with non-proteinuric nephropathies. Half of the patients will receive angiotensin converting enzyme inhibitors, while the other half will not receive them. Renal function, proteinuria and cardiovascular events will be follow up during a three year period.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Proteinuria Drug: Lisinopril Drug: Amlodipine Phase 4

Detailed Description:

STUDY DESIGN: Open, multicentre, prospective, parallel-group, randomized controlled study comparing the effect of an angiotensin converting enzyme inhibitor (ACEI) vs standard antihypertensive treatment without ACEI, in the progression of renal disease in elderly patients with non-proteinuric 3-4 stage chronic renal disease.

Elderly patients (> 65 years) with moderate-severe non-proteinuric chronic renal disease (estimated Glomerular Filtrate Rate between 19-59 ml per minute per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration Group equation) and urine-creatinine rate < 30 mg/g, will be included. They will be randomly assigned in a 1:1 ratio to receive ACEI or standard antihypertensive treatment. Patients will be followed up for 3 years.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Renin-angiotensin System Blocker Drugs on Chronic Kidney Disease Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01)
Study Start Date : June 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: RAS Blockers
Patients in this arm will receive Lisinopril 20mg/day
Drug: Lisinopril
Other Name: Angiotensin converting enzyme inhibitors

Active Comparator: Non RAS Blockers
Patients in this arm will receive Amlodipine 10mg/day or Lercanidipine 20mg/day +/- diuretics
Drug: Amlodipine
Patients in this arm will receive antihypertensive treatment different from RAS blockers. If they previously received RAS blockers, they will be substitute for either Amlodipine or Lercanidipine +/- diuretics
Other Name: Lercanidipine, Furosemide, Thiazides




Primary Outcome Measures :
  1. Chronic kidney disease progression [ Time Frame: 3 years ]
    Increase of baseline creatinine during follow up period


Secondary Outcome Measures :
  1. Security of RAS blockers in elderly patients [ Time Frame: 3 YEARS ]
    Evaluate the frequency of hiperpotassemia (K>5.5 mmol/l)

  2. Security of RAS blockers in elderly patients [ Time Frame: 3 YEARS ]
    Evaluate the frequency of acute kidney failure (>Cr 0.3 mg/dl)

  3. Effect of RAS blockers on mortality in elderly patients [ Time Frame: 3 YEARS ]
    Evaluate the number and cause of deaths in the study population

  4. Effects of RAS blockers on cardiovascular risk in elderly patients [ Time Frame: 3 YEARS ]
    Evaluate and classify cardiovascular events (heart failure, acute coronary syndrome, peripheral vasculopathy) during the follow up period



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >65 years
  • Chronic kidney disease stage 3 or 4 (GFR measured by CKD-EPI 15-59 ml/min/1,73 m2)
  • Albumine/creatinine index < 30 mg/g in simple urine sample or albuminuria < 30 mg/day in 24-hour urine sample.
  • Previous hypertensive treatment::

    1. patients who have not received RAS blockers in the three months prior to inclusion can be included
    2. patients who are receiving RAS blockers could be included after one month washout period

Exclusion Criteria:

  • Diabetes mellitus (type 1 or 2)
  • Glomerulopathy
  • Chronic heart failure or coronary heart disease
  • Poorly controlled hypertension (>160/100 mmHg)
  • Active malignant neoplasia (except skin cancer different from melanoma). Patients who have been free of malignancy for the last 5 years could be included.
  • Chronic symptomatic or not controlled inflammatory disease (eg rheumatoid arthritis, Chron disease, ulcerative colitis or systemic lupus erythematosus)
  • Chronic liver disease
  • Allergy or intolerance to renin angiotensin system blockers or calcium channel blockers
  • Hepatitis B, C or HIV infection
  • Immunosuppressive treatment in the 3 months prior to inclusion
  • Hospitalization of any cause in the three months prior to inclusion
  • Rapidly progressive kidney disease (decline in GFR >5ml/min/1.73 m2/year)
  • Inability to sign the informed consent

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 ClinicalTrials.gov identifier (NCT number): NCT03195023


Contacts
Contact: Maria Angeles Goicoechea, PhD, MD 0034609838684 marian.goicoechea@gmail.com
Contact: Ana Maria Garcia Prieto, MD 0034676611045 anamgarciaprieto@gmail.com

Locations
Spain
Gregorio Maranon Hospital Recruiting
Madrid, Spain, 28007
Contact: Maria Angeles Goicoechea, PhD, MD    0034609838684    marian.goicoechea@gmail.com   
Contact: Ana María García, MD    0034676611045    anamgarciaprieto@gmail.com   
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Investigators
Principal Investigator: Maria Angeles Goicoechea, PhD, MD Hospital General Universitario Gregorio Marañon

Publications:

Responsible Party: Maria Maria Angeles Goicoechea Diezhandino, Nefrologist, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT03195023     History of Changes
Other Study ID Numbers: PROERCAN01
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by Maria Maria Angeles Goicoechea Diezhandino, Hospital General Universitario Gregorio Marañon:
Renal Insufficiency, Chronic

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Disease Progression
Proteinuria
Urologic Diseases
Disease Attributes
Pathologic Processes
Urination Disorders
Urological Manifestations
Signs and Symptoms
Lercanidipine
Amlodipine
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protease Inhibitors
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs