Remission Clinic in Proteinuric Chronic Nephropathies

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02721342
• Other study ID #: Remission Clinic
• Status: Active, not recruiting
• Start date: June 2009
• Est. completion date: November 2022

Study information

• Verified date: February 2022
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Ramipril, Irbesartan and Atorvastin

Locations

Country	Name	City	State
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 Morgagni - Pierantoni - U.O. Nefrologia e Dialisi	Forlì	Forli'
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	Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò	Ranica	Bergamo
Italy	Asl 6 Sanluri-P.O. Nostra Signora di Bonaria - U.O. Nefrologia e Dialisi	San Gavino- Monreale	Medio Campidano - VS
Italy	Ospedale di Circolo Fondazione Macchi - U.O. Nefrologia e Dialisi	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Secondary	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.