Chronic Kidney DiseaseNCT02721342
Remission Clinic in Proteinuric Chronic Nephropathies
An observational study of Chronic Kidney Disease, run by Mario Negri Institute for Pharmacological Research at 13 sites in Italy.
Trial summary
Most chronic kidney diseases have a progressive evolution characterized by the gradual loss of glomerular filtration rate (GFR), electrolytic imbalance, reduced erythropoietin synthesis and activation of vitamin D. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Ramipril, Irbesartan and Atorvastin
- How many people
- 1,500 participants
- Where
- 13 sitesItaly
- Study dates
- Jun 2009to Nov 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetic or non-diabetic chronic nephropathies, with no specific contraindications for treatment with ACEi or Sartans.
Who may be able to join
- Proteinuria >0.5 g/24 hours or albuminuria >200 g / min (or >300 g/24 hours) for at least 2 consecutive evaluations regardless of treatment with ACEi and/or ARBs;
- Change in serum creatinine or creatinine clearance less than 30% in the last 3 months;
- No corticosteroids or immunosuppressants at the time of inclusion or given to patient in the last 6 months.
Who cannot join
- Idiopathic membranous nephropathy;
- Focal segmental glomerulosclerosis;
- Minimal change glomerulopathy;
- Nephritic syndrome;
- Rapidly progressive renal failure (extracapillary glomerulonephritis in active phase);
- Any active renal disease that represents a possible indication to corticosteroids or immunosuppressive therapy;
- Nephropathies secondary to systemic disease susceptible to treatment with corticosteroids or immunosuppressive agents (Systemic Lupus Erythematosus, Vasculitis, Amyloidosis, etc.).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
Ospedale C.G. Mazzoni Zona 13 ASUR Marche - U.O. Nefrologia e Dialisi
Ascoli Piceno, 63100
AORN Moscati - Avellino - U.O. Nefrologia e Dialisi
Avellino, 83100
A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi
Bergamo, 20147
A.O. Papa Giovanni XXIII Bergamo - U.O. Diabetologia
Bergamo, 20147
Azienda Ospedaliera G. Brotzu - U.O. Nefrologia e Dialisi
Cagliari, 09100
Ospedale Morgagni - Pierantoni - U.O. Nefrologia e Dialisi
Forlì, Forli', 47011
Ospedale Campo di Marte - USL 2 - U.O. Nefrologia
Lucca, 55100
ARNAS Ospedale Civico Di Cristina Benfratelli - U.O. Nefrologia e Dialisi
Palermo, 90127
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Università degli Studi di Palermo - Dipartimento Malattie Cardiovascolari e Nefrourologiche - U.O. Tecniche Dialitiche
Palermo, 90129
Azienda Ospedaliera Universitaria Pisana - U.O. Nefrologia e Dialisi 2
Pisa, 56126
Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò
Ranica, Bergamo, 24020
Asl 6 Sanluri-P.O. Nostra Signora di Bonaria - U.O. Nefrologia e Dialisi
San Gavino Monreale, Medio Campidano - VS, 09037
Ospedale di Circolo Fondazione Macchi - U.O. Nefrologia e Dialisi
Varese, 21100
About this study
Official title: Remission Clinic: Computed Registry for the Ambulatory Follow up of Patients With Proteinuric Chronic Nephropathies Treated Based on a Standard Multipharmacological Model Aimed at Normalizing Proteinuria and Stabilizing the Renal Function
Most chronic kidney diseases have a progressive evolution characterized by the gradual loss of glomerular filtration rate (GFR), electrolytic imbalance, reduced erythropoietin synthesis and activation of vitamin D. On many occasions, the progressive deterioration of renal function occurs, even when the etiologic factors responsible for the kidney disease are treated and/or eliminated as a result of an auto-sustained mechanism of inflammation and fibrosis. Moreover, chronic nephropathies are often associated with high blood pressure and increased urine protein excretion, being both risk factors of progression toward kidney failure. Many clinical studies have shown the efficacy of antihypertensive therapies, particularly the blockade of renin-angiotensin system, to lower the abnormal urinary protein excretion. Moreover, control of blood pressure and proteinuria slow the rate of renal function decline and in some cases even lead to recovery of kidney function avoiding the need for renal replacement therapies. The set of measures to achieve these results encompasses the term of "renoprotective therapy". However these achievements have been obtained in the setting of clinical trials, and need confirmation in the daily clinical practice.
To this purpose a standardized multidrug intervention model that aims at normalizing the excretion of urinary proteins and stabilizing the renal function has been developed for the outpatient-clinic and named "Remission Clinic".
The applicability of this protocol is aimed for all nephrology and diabetology centers. Through the use of a dedicated database computer network, it will be possible to share clinical, laboratory and treatment data, recorded for each patient enrolled in the Remission Clinic program. With this system, it will be possible to verify if the multidrug approach of the Remission Clinic will allow to improve the clinical course of chronic proteinuric nephropathy. All participants (centers) may access to the Remission Clinic website developed, updated and maintained by the Department of Bioengineering of the Mario Negri Institute, Bergamo, Italy.
- Conditions
- Chronic Kidney Disease
- Being tested
- Ramipril, Irbesartan and Atorvastin
- Keywords
- Chronic proteinuric nephropathies
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramipril, Irbesartan and AtorvastinDrug
| Study group | Role | What they receive |
|---|---|---|
| Ramipril, Irbesartan and Atorvastin treatment | A multidrug approach, including Angiotensin II Converting Enzyme (ACE) inhibitor, Ramipril, and Angiotensin II Receptor Blocker (ARB), Irbesartan, and Atorvastin will be done. Treatment doses of drugs will be up-titrated gradually considering the tolerability. Receives: Drug: Ramipril, Irbesartan and Atorvastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular Filtration Rate (GFR) estimated
Measured: Changes from baseline at at least every 3 to 6 months for the duration of the study, an expected average of 10 years.
24 hour proteinuria
Measured: Changes from baseline at at least every 3 to 6 months for the duration of the study, an expected average of 10 years.
Secondary outcomes (1)
Number of participants with fatal and non-fatal cardiovascular events
Sudden death, myocardial infarction, unstable angina, stroke, transient ischemic attack, lower limb amputation, coronary, carotid or peripheral vessel revascularization.
Measured: Participants will be followed for the duration of the study, an expected average of 10years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startJun 2009
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721342
- Sponsor's protocol ID
- Remission Clinic
- Status last verified
- Feb 2022
- First submitted
- 14 Mar 2016
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remission Clinic: Computed Registry for the Ambulatory Follow up of Patients With Proteinuric Chronic Nephropathies Treated Based on a Standard Multipharmacological Model Aimed at Normalizing Proteinuria and Stabilizing the Renal Function
- ClinicalTrials.gov ID
- NCT02721342
- Acronym / sponsor ID
- Remission Clinic
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic proteinuric nephropathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 29 Mar 2016 (estimated)
- 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.
Most chronic kidney diseases have a progressive evolution characterized by the gradual loss of glomerular filtration rate (GFR), electrolytic imbalance, reduced erythropoietin synthesis and activation of vitamin D. On many occasions, the progressive deterioration of renal function occurs, even when the etiologic factors responsible for the kidney disease are treated and/or eliminated as a result of an auto-sustained mechanism of inflammation and fibrosis. Moreover, chronic nephropathies are often associated with high blood pressure and increased urine protein excretion, being both risk factors of progression toward kidney failure. Many clinical studies have shown the efficacy of antihypertensive therapies, particularly the blockade of renin-angiotensin system, to lower the abnormal urinary protein excretion. Moreover, control of blood pressure and proteinuria slow the rate of renal function decline and in some cases even lead to recovery of kidney function avoiding the need for renal replacement therapies. The set of measures to achieve these results encompasses the term of "renoprotective therapy". However these achievements have been obtained in the setting of clinical trials, and need confirmation in the daily clinical practice.
To this purpose a standardized multidrug intervention model that aims at normalizing the excretion of urinary proteins and stabilizing the renal function has been developed for the outpatient-clinic and named "Remission Clinic".
The applicability of this protocol is aimed for all nephrology and diabetology centers. Through the use of a dedicated database computer network, it will be possible to share clinical, laboratory and treatment data, recorded for each patient enrolled in the Remission Clinic program. With this system, it will be possible to verify if the multidrug approach of the Remission Clinic will allow to improve the clinical course of chronic proteinuric nephropathy. All participants (centers) may access to the Remission Clinic website developed, updated and maintained by the Department of Bioengineering of the Mario Negri Institute, Bergamo, Italy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramipril, Irbesartan and Atorvastin treatment | – | Drug: Ramipril, Irbesartan and AtorvastinA multidrug approach, including Angiotensin II Converting Enzyme (ACE) inhibitor, Ramipril, and Angiotensin II Receptor Blocker (ARB), Irbesartan, and Atorvastin will be done. Treatment doses of drugs will be up-titrated gradually considering the tolerability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetic or non-diabetic chronic nephropathies, with no specific contraindications for treatment with ACEi or Sartans.
Key inclusion criteria (3 listed)
- Proteinuria >0.5 g/24 hours or albuminuria >200 g / min (or >300 g/24 hours) for at least 2 consecutive evaluations regardless of treatment with ACEi and/or ARBs;
- Change in serum creatinine or creatinine clearance less than 30% in the last 3 months;
- No corticosteroids or immunosuppressants at the time of inclusion or given to patient in the last 6 months.
Key exclusion criteria (7 listed)
- Idiopathic membranous nephropathy;
- Focal segmental glomerulosclerosis;
- Minimal change glomerulopathy;
- Nephritic syndrome;
- Rapidly progressive renal failure (extracapillary glomerulonephritis in active phase);
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 |
|---|---|---|
| Ramipril, Irbesartan and Atorvastin | Drug | Ramipril, Irbesartan and Atorvastin treatment |
Primary outcome
Glomerular Filtration Rate (GFR) estimated
Time frame: Changes from baseline at at least every 3 to 6 months for the duration of the study, an expected average of 10 years.
24 hour proteinuria
Time frame: Changes from baseline at at least every 3 to 6 months for the duration of the study, an expected average of 10 years.
1 secondary outcome
Number of participants with fatal and non-fatal cardiovascular events
Time frame: Participants will be followed for the duration of the study, an expected average of 10years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Mario Negri Institute for Pharmacological Research at 13 sites in Italy.
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 3 inclusion and 7 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 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular Filtration Rate (GFR) estimated (time frame: Changes from baseline at at least every 3 to 6 months for the duration of the study, an expected average of 10 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2022.