Remission Clinic in Proteinuric Chronic Nephropathies

NCT ID: NCT02721342

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2022-11-30

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ramipril, Irbesartan and Atorvastin

Intervention Type: DRUG

Interventions

Ramipril, Irbesartan and Atorvastin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò

Ranica, Bergamo, Italy

Ospedale Morgagni - Pierantoni - U.O. Nefrologia e Dialisi

Forlì, Forli', Italy

Asl 6 Sanluri-P.O. Nostra Signora di Bonaria - U.O. Nefrologia e Dialisi

San Gavino Monreale, Medio Campidano - VS, Italy

Ospedale C.G. Mazzoni Zona 13 ASUR Marche - U.O. Nefrologia e Dialisi

Ascoli Piceno, , Italy

AORN Moscati - Avellino - U.O. Nefrologia e Dialisi

Avellino, , Italy

A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi

Bergamo, , Italy

A.O. Papa Giovanni XXIII Bergamo - U.O. Diabetologia

Bergamo, , Italy

Azienda Ospedaliera G. Brotzu - U.O. Nefrologia e Dialisi

Cagliari, , Italy

Ospedale Campo di Marte - USL 2 - U.O. Nefrologia

Lucca, , Italy

ARNAS Ospedale Civico Di Cristina Benfratelli - U.O. Nefrologia e Dialisi

Palermo, , Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Università degli Studi di Palermo - Dipartimento Malattie Cardiovascolari e Nefrourologiche - U.O. Tecniche Dialitiche

Palermo, , Italy

Azienda Ospedaliera Universitaria Pisana - U.O. Nefrologia e Dialisi 2

Pisa, , Italy

Ospedale di Circolo Fondazione Macchi - U.O. Nefrologia e Dialisi

Varese, , Italy

Countries

Italy

Other Identifiers

Remission Clinic

Identifier Type: -

Identifier Source: org_study_id