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

NCT03195023 | Unknown Phase 4

• 1 other identifier: PROERCAN01
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic; Proteinuria

Keywords

Renal insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• Chronic kidney disease progression

  Increase of baseline creatinine during follow up period

  3 years

Secondary Outcomes (4)

• Security of RAS blockers in elderly patients

  3 years

• Security of RAS blockers in elderly patients

  3 years

• Effect of RAS blockers on mortality in elderly patients

  3 years

• Effects of RAS blockers on cardiovascular risk in elderly patients

  3 years

Study Arms (2)

RAS Blockers

ACTIVE COMPARATOR

Patients in this arm will receive Lisinopril 20mg/day

Drug: Lisinopril

Non RAS Blockers

ACTIVE COMPARATOR

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

Drug: Amlodipine

Interventions

Lisinopril DRUG

Also known as: Angiotensin converting enzyme inhibitors

RAS Blockers

Amlodipine DRUG

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

Also known as: Lercanidipine, Furosemide, Thiazides

Non RAS Blockers

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 are receiving RAS blockers could be included after one month washout period

You may not qualify if:

• 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
• Rapidly progressive kidney disease (decline in GFR \>5ml/min/1.73 m2/year)
• Inability to sign the informed consent

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (1)

Gregorio Maranon Hospital

Madrid, 28007, Spain

RECRUITING

Related Publications (7)

• 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.

  PMID: 12965979 BACKGROUND

• 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.

  PMID: 12435255 BACKGROUND

• 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.

  PMID: 19451579 BACKGROUND

• 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.

  PMID: 19820248 BACKGROUND

• 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.

  PMID: 20539228 BACKGROUND

• 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.

  PMID: 20498247 BACKGROUND

• Garcia-Prieto AM, Verdalles U, de Jose AP, Arroyo D, Aragoncillo I, Barbieri D, Camacho RE, Goicoechea M. Renin-angiotensin-aldosterone system blockers effect in chronic kidney disease progression in hypertensive elderly patients without proteinuria: PROERCAN trial. Hipertens Riesgo Vasc. 2024 Apr-Jun;41(2):95-103. doi: 10.1016/j.hipert.2023.11.005. Epub 2024 Mar 19.

  PMID: 38508877 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria

Interventions

Lisinopril; Angiotensin-Converting Enzyme Inhibitors; Amlodipine; lercanidipine; Furosemide; Thiazides

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Maria Angeles Goicoechea, PhD, MD

  Hospital General Universitario Gregorio Marañon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Angeles Goicoechea, PhD, MD

CONTACT

0034609838684; marian.goicoechea@gmail.com

Ana Maria Garcia Prieto, MD

CONTACT

0034676611045; anamgarciaprieto@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nefrologist

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 22, 2017
• Study Start: June 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

ES (1)