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

  • STATUS
    Recruiting
  • days left to enroll
    18
  • participants needed
    106
  • sponsor
    Hospital General Universitario Gregorio Marañon
Updated on 23 January 2021
renal function
enzyme inhibitors
ace inhibitor
angiotensin
nephropathy
chronic kidney disease
renin
antihypertensive
amlodipine
proteinuria
angiotensin converting enzyme

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.

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.

Details
Condition chronic renal insufficiency, Proteinuria, Proteinuria
Treatment Amlodipine, Lisinopril, Lisinopril
Clinical Study IdentifierNCT03195023
SponsorHospital General Universitario Gregorio Marañon
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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)
Active malignant neoplasia (except skin cancer different from melanoma). Patients who have been free of malignancy for the last 5 years could be included
Monorrenal
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note