Renal Insufficiency, ChronicPhase 4PROERCAN01NCT03195023
Effect of RAS Blockers on CKD Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01)
A Phase 4 study testing Lisinopril and Amlodipine in people with Renal Insufficiency, Chronic and Proteinuria, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Proteinuria
- What is being tested?
- Lisinopril and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Gregorio Maranon Hospital
Madrid, 28007
Maria Angeles Goicoechea, PhD, MD, 0034609838684, marian.goicoechea@gmail.com
Ana María García, MD, 0034676611045, anamgarciaprieto@gmail.com
About this study
Official title: Effect of Renin-angiotensin-system (RAS) Blocker Drugs on Chronic Kidney Disease (CKD) Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01)
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.
Read the 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.
- Conditions
- Renal Insufficiency, Chronic, Proteinuria
- Being tested
- Lisinopril, Amlodipine
- Keywords
- Renal insufficiency, Chronic
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisinoprilDrug
Also called Angiotensin converting enzyme inhibitors
AmlodipineDrug
Also called Lercanidipine, Furosemide, Thiazides
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
| Study group | Role | What they receive |
|---|---|---|
| RAS Blockers | Active comparator | Patients in this arm will receive Lisinopril 20mg/day Receives: Drug: Lisinopril |
| Non RAS Blockers | Active comparator | Patients in this arm will receive Amlodipine 10mg/day or Lercanidipine 20mg/day +/- diuretics Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic kidney disease progression
Increase of baseline creatinine during follow up period
Measured: 3 years
Secondary outcomes (4)
Security of RAS blockers in elderly patients
Evaluate the frequency of hiperpotassemia (K>5.5 mmol/l)
Measured: 3 years
Security of RAS blockers in elderly patients
Evaluate the frequency of acute kidney failure (>Cr 0.3 mg/dl)
Measured: 3 years
Effect of RAS blockers on mortality in elderly patients
Evaluate the number and cause of deaths in the study population
Measured: 3 years
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study startJun 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Maria Angeles Goicoechea Diezhandino, Hospital General Universitario Gregorio Marañon
- Investigators
- Maria Angeles Goicoechea, PhD, MD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195023
- Sponsor's protocol ID
- PROERCAN01
- Acronym
- PROERCAN01
- Status last verified
- Feb 2019
- First submitted
- 14 Jun 2017
- Last updated
- 22 Feb 2019
- Results posted
- No
Publications
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.
PubMed 12965979Wright 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.
PubMed 12435255O'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.
PubMed 19451579Ahmed 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.
PubMed 19820248Weiss 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.
PubMed 20539228Turgut 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.
PubMed 20498247Garcia-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.
PubMed 38508877
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Renin-angiotensin-system (RAS) Blocker Drugs on Chronic Kidney Disease (CKD) Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01)
- ClinicalTrials.gov ID
- NCT03195023
- Acronym / sponsor ID
- PROERCAN01 / PROERCAN01
- Conditions
- Renal Insufficiency, Chronic, Proteinuria
- Keywords
- Renal insufficiency, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAS Blockers | Active comparator | Drug: LisinoprilPatients in this arm will receive Lisinopril 20mg/day |
| Non RAS Blockers | Active comparator | Drug: AmlodipinePatients in this arm will receive Amlodipine 10mg/day or Lercanidipine 20mg/day +/- diuretics |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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::
Key exclusion criteria (14 listed)
- Diabetes mellitus (type 1 or 2)
- Glomerulopathy
- Chronic heart failure or coronary heart disease
- Poorly controlled hypertension (>160/100 mmHg)
- Monorrenal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LisinoprilAlso: Angiotensin converting enzyme inhibitors | Drug | RAS Blockers |
| AmlodipineAlso: Lercanidipine, Furosemide, ThiazidesPatients 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 | Drug | Non RAS Blockers |
Primary outcome
Chronic kidney disease progression
Time frame: 3 years
Increase of baseline creatinine during follow up period
4 secondary outcomes
Security of RAS blockers in elderly patients
Time frame: 3 years
Security of RAS blockers in elderly patients
Time frame: 3 years
Effect of RAS blockers on mortality in elderly patients
Time frame: 3 years
Effects of RAS blockers on cardiovascular risk in elderly patients
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Background: PubMed 12965979Jafar 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.
- Background: PubMed 12435255Wright 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.
- Background: PubMed 19451579O'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.
- Background: PubMed 19820248Ahmed 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.
- Background: PubMed 20539228Weiss 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.
- Background: PubMed 20498247Turgut 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.
- Derived from this study: PubMed 38508877Garcia-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Angeles Goicoechea, PhD, MD principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lisinopril and Amlodipine in people with Renal Insufficiency, Chronic and Proteinuria, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Angeles Goicoechea, PhD, MD (0034609838684, marian.goicoechea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic kidney disease progression (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195023, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.