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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Renin-angiotensin-system (RAS) Blocker Drugs on Chronic Kidney Disease (CKD) Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01)

Conditions
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Renal Insufficiency, Chronic, Proteinuria

Intervention / Treatment
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* Drug: Lisinopril
* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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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:: patients who have not received RAS blockers in the three months prior to inclusion can be included 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RAS Blockers<br>Patients in this arm will receive Lisinopril 20mg/day | Drug: Lisinopril<br> <br> * Other names: Angiotensin converting enzyme inhibitors;|
| Active Comparator: Non RAS Blockers<br>Patients in this arm will receive Amlodipine 10mg/day or Lercanidipine 20mg/day +/- diuretics | Drug: Amlodipine<br>* 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<br>* Other names: Lercanidipine, Furosemide, Thiazides;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic kidney disease progression | Increase of baseline creatinine during follow up period | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Security of RAS blockers in elderly patients | Evaluate the frequency of hiperpotassemia (K>5.5 mmol/l) | 3 years | 
| Security of RAS blockers in elderly patients | Evaluate the frequency of acute kidney failure (>Cr 0.3 mg/dl) | 3 years | 
| Effect of RAS blockers on mortality in elderly patients | Evaluate the number and cause of deaths in the study population | 3 years | 
| Effects of RAS blockers on cardiovascular risk in elderly patients | Evaluate and classify cardiovascular events (heart failure, acute coronary syndrome, peripheral vasculopathy) during the follow up period | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal insufficiency, Chronic