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

February 21, 2019 updated by: Maria Maria Angeles Goicoechea Diezhandino, Hospital General Universitario Gregorio Marañon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RAS Blockers
Patients in this arm will receive Lisinopril 20mg/day
Drug: Lisinopril
Other Names:
  • 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 Names:
  • Lercanidipine, Furosemide, Thiazides

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic kidney disease progression
Time Frame: 3 years
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
Time Frame: 3 years
Evaluate the frequency of hiperpotassemia (K>5.5 mmol/l)
3 years
Security of RAS blockers in elderly patients
Time Frame: 3 years
Evaluate the frequency of acute kidney failure (>Cr 0.3 mg/dl)
3 years
Effect of RAS blockers on mortality in elderly patients
Time Frame: 3 years
Evaluate the number and cause of deaths in the study population
3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Investigators

  • Principal Investigator: Maria Angeles Goicoechea, PhD, MD, Hospital General Universitario Gregorio Maranon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROERCAN01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Insufficiency, Chronic

Clinical Trials on Lisinopril

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe