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

Primary Purpose

Renal Insufficiency, Chronic, Proteinuria

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Lisinopril

Amlodipine

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Renal insufficiency, Chronic

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

Gregorio Maranon HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

RAS Blockers

Non RAS Blockers

Arm Description

Patients in this arm will receive Lisinopril 20mg/day

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

Outcomes

Primary Outcome Measures

Chronic kidney disease progression

Increase of baseline creatinine during follow up period

Secondary Outcome Measures

Security of RAS blockers in elderly patients

Evaluate the frequency of hiperpotassemia (K>5.5 mmol/l)

Security of RAS blockers in elderly patients

Evaluate the frequency of acute kidney failure (>Cr 0.3 mg/dl)

Effect of RAS blockers on mortality in elderly patients

Evaluate the number and cause of deaths in the study population

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

Full Information

NCT ID

NCT03195023

First Posted

June 14, 2017

Last Updated

February 21, 2019

Sponsor

Hospital General Universitario Gregorio Marañon

1. Study Identification

Unique Protocol Identification Number

NCT03195023

Brief Title

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

Acronym

PROERCAN01

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital General Universitario Gregorio Marañon

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency, Chronic, Proteinuria

Keywords

Renal insufficiency, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RAS Blockers

Arm Type

Active Comparator

Arm Description

Patients in this arm will receive Lisinopril 20mg/day

Arm Title

Non RAS Blockers

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lisinopril

Other Intervention Name(s)

Angiotensin converting enzyme inhibitors

Intervention Type

Drug

Intervention Name(s)

Amlodipine

Other Intervention Name(s)

Lercanidipine, Furosemide, Thiazides

Intervention Description

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

Primary Outcome Measure Information:

Title

Chronic kidney disease progression

Description

Increase of baseline creatinine during follow up period

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Security of RAS blockers in elderly patients

Description

Evaluate the frequency of hiperpotassemia (K>5.5 mmol/l)

Time Frame

3 years

Title

Security of RAS blockers in elderly patients

Description

Evaluate the frequency of acute kidney failure (>Cr 0.3 mg/dl)

Time Frame

3 years

Title

Effect of RAS blockers on mortality in elderly patients

Description

Evaluate the number and cause of deaths in the study population

Time Frame

3 years

Title

Effects of RAS blockers on cardiovascular risk in elderly patients

Description

Evaluate and classify cardiovascular events (heart failure, acute coronary syndrome, peripheral vasculopathy) during the follow up period

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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:: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Angeles Goicoechea, PhD, MD

Phone

0034609838684

marian.goicoechea@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ana Maria Garcia Prieto, MD

Phone

0034676611045

anamgarciaprieto@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Angeles Goicoechea, PhD, MD

Organizational Affiliation

Hospital General Universitario Gregorio Marañon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gregorio Maranon Hospital

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Angeles Goicoechea, PhD, MD

Phone

0034609838684

marian.goicoechea@gmail.com

First Name & Middle Initial & Last Name & Degree

Ana María García, MD

Phone

0034676611045

anamgarciaprieto@gmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

12965979

Citation

Jafar TH, Stark PC, Schmid CH, Landa M, Maschio G, de Jong PE, de Zeeuw D, Shahinfar S, Toto R, Levey AS; AIPRD Study Group. Progression of chronic kidney disease: the role of blood pressure control, proteinuria, and angiotensin-converting enzyme inhibition: a patient-level meta-analysis. Ann Intern Med. 2003 Aug 19;139(4):244-52. doi: 10.7326/0003-4819-139-4-200308190-00006.

Results Reference

background

PubMed Identifier

12435255

Citation

Wright JT Jr, Bakris G, Greene T, Agodoa LY, Appel LJ, Charleston J, Cheek D, Douglas-Baltimore JG, Gassman J, Glassock R, Hebert L, Jamerson K, Lewis J, Phillips RA, Toto RD, Middleton JP, Rostand SG; African American Study of Kidney Disease and Hypertension Study Group. Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial. JAMA. 2002 Nov 20;288(19):2421-31. doi: 10.1001/jama.288.19.2421. Erratum In: JAMA. 2006 Jun 21;295(23):2726.

Results Reference

background

PubMed Identifier

19451579

Citation

O'Hare AM, Kaufman JS, Covinsky KE, Landefeld CS, McFarland LV, Larson EB. Current guidelines for using angiotensin-converting enzyme inhibitors and angiotensin II-receptor antagonists in chronic kidney disease: is the evidence base relevant to older adults? Ann Intern Med. 2009 May 19;150(10):717-24. doi: 10.7326/0003-4819-150-10-200905190-00010.

Results Reference

background

PubMed Identifier

19820248

Citation

Ahmed AK, Kamath NS, El Kossi M, El Nahas AM. The impact of stopping inhibitors of the renin-angiotensin system in patients with advanced chronic kidney disease. Nephrol Dial Transplant. 2010 Dec;25(12):3977-82. doi: 10.1093/ndt/gfp511. Epub 2009 Oct 10.

Results Reference

background

PubMed Identifier

20539228

Citation

Weiss JW, Thorp ML, O'Hare AM. Renin-angiotensin system blockade in older adults with chronic kidney disease: a review of the literature. Curr Opin Nephrol Hypertens. 2010 Sep;19(5):413-9. doi: 10.1097/MNH.0b013e32833b8d6b.

Results Reference

background

PubMed Identifier

20498247

Citation

Turgut F, Balogun RA, Abdel-Rahman EM. Renin-angiotensin-aldosterone system blockade effects on the kidney in the elderly: benefits and limitations. Clin J Am Soc Nephrol. 2010 Jul;5(7):1330-9. doi: 10.2215/CJN.08611209. Epub 2010 May 24.

Results Reference

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

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