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

Renal Insufficiency, Chronic Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03195023
• Other study ID #: PROERCAN01
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2015
• Est. completion date: December 2022

Study information

• Verified date: February 2019
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Maria Angeles Goicoechea, PhD, MD
• Phone: 0034609838684
• Email: marian.goicoechea[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 2022
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Proteinuria
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Lisinopril

• 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

Locations

Country	Name	City	State
Spain	Gregorio Maranon Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. Erratum in: JAMA. 2006 Jun 21;295(23):2726. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic kidney disease progression	Increase of baseline creatinine during follow up period	3 years
Secondary	Security of RAS blockers in elderly patients	Evaluate the frequency of hiperpotassemia (K>5.5 mmol/l)	3 years
Secondary	Security of RAS blockers in elderly patients	Evaluate the frequency of acute kidney failure (>Cr 0.3 mg/dl)	3 years
Secondary	Effect of RAS blockers on mortality in elderly patients	Evaluate the number and cause of deaths in the study population	3 years
Secondary	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