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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramipril, Irbesartan and Atorvastin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular Filtration Rate (GFR) estimated | 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 | Changes from baseline at at least every 3 to 6 months for the duration of the study, an expected average of 10 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for the duration of the study, an expected average of 10years. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diabetic or non-diabetic chronic nephropathies, with no specific contraindications for treatment with ACEi or Sartans.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò | Ranica | Bergamo | 24020 | Italy | ||
| Ospedale Morgagni - Pierantoni - U.O. Nefrologia e Dialisi |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017257 | Ramipril |
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
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| Forlì |
| Forli' |
| 47011 |
| Italy |
| Asl 6 Sanluri-P.O. Nostra Signora di Bonaria - U.O. Nefrologia e Dialisi | San Gavino Monreale | Medio Campidano - VS | 09037 | Italy |
| Ospedale C.G. Mazzoni Zona 13 ASUR Marche - U.O. Nefrologia e Dialisi | Ascoli Piceno | 63100 | Italy |
| AORN Moscati - Avellino - U.O. Nefrologia e Dialisi | Avellino | 83100 | Italy |
| A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi | Bergamo | 20147 | Italy |
| A.O. Papa Giovanni XXIII Bergamo - U.O. Diabetologia | Bergamo | 20147 | Italy |
| Azienda Ospedaliera G. Brotzu - U.O. Nefrologia e Dialisi | Cagliari | 09100 | Italy |
| Ospedale Campo di Marte - USL 2 - U.O. Nefrologia | Lucca | 55100 | Italy |
| ARNAS Ospedale Civico Di Cristina Benfratelli - U.O. Nefrologia e Dialisi | Palermo | 90127 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, UniversitĂ degli Studi di Palermo - Dipartimento Malattie Cardiovascolari e Nefrourologiche - U.O. Tecniche Dialitiche | Palermo | 90129 | Italy |
| Azienda Ospedaliera Universitaria Pisana - U.O. Nefrologia e Dialisi 2 | Pisa | 56126 | Italy |
| Ospedale di Circolo Fondazione Macchi - U.O. Nefrologia e Dialisi | Varese | 21100 | Italy |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011083 | Polycyclic Compounds |