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

Hospital General Universitario Gregorio Marañon

Status and phase: Unknown; Phase 4

Conditions: Proteinuria; Renal Insufficiency, Chronic

Treatments: Drug: Amlodipine; Drug: Lisinopril

Study type: Interventional

Funder types: Other

Identifiers

NCT03195023

PROERCAN01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)
• Monorrenal
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

RAS Blockers

Active Comparator group

Description:

Patients in this arm will receive Lisinopril 20mg/day

Treatment:

Drug: Lisinopril

Non RAS Blockers

Active Comparator group

Description:

Patients in this arm will receive Amlodipine 10mg/day or Lercanidipine 20mg/day +/- diuretics

Treatment:

Drug: Amlodipine