Effect of RAS Blockers on CKD Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01)
NCT ID: NCT03195023
Last Updated: 2019-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
106 participants
INTERVENTIONAL
2015-06-30
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria
NCT01541267
Proteomic Prediction and Renin Angiotensin Aldosterone System Inhibition Prevention Of Early Diabetic nephRopathy In TYpe 2 Diabetic Patients With Normoalbuminuria
NCT02040441
CR Aim #2 - AT1 Receptor Blockade & ACE Inhibition Effect on Humoral Function
NCT01678794
Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy
NCT01525888
Optimalization of Nephroprotection Using Agents Inhibiting Renin-Angiotensin-Aldosterone System
NCT00528385
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RAS Blockers
Patients in this arm will receive Lisinopril 20mg/day
Lisinopril
Non RAS Blockers
Patients in this arm will receive Amlodipine 10mg/day or Lercanidipine 20mg/day +/- diuretics
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital General Universitario Gregorio Marañon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maria Maria Angeles Goicoechea Diezhandino
Nefrologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria Angeles Goicoechea, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gregorio Maranon Hospital
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PROERCAN01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.