Remission Clinic in Proteinuric Chronic Nephropathies

NCT02721342 | Unknown

• 1 other identifier: Remission Clinic
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 13

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

Keywords

Chronic proteinuric nephropathies

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• Number of participants with fatal and non-fatal cardiovascular events

  Participants will be followed for the duration of the study, an expected average of 10years.

Study Arms (1)

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.

Drug: Ramipril, Irbesartan and Atorvastin

Interventions

Ramipril, Irbesartan and Atorvastin DRUG

Ramipril, Irbesartan and Atorvastin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diabetic or non-diabetic chronic nephropathies, with no specific contraindications for treatment with ACEi or Sartans.

You may qualify if:

• 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;

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (13)

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

Ranica, Bergamo, 24020, Italy

Location

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

Forlì, Forli', 47011, Italy

Location

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

San Gavino Monreale, Medio Campidano - VS, 09037, Italy

Location

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

Ascoli Piceno, 63100, Italy

Location

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

Avellino, 83100, Italy

Location

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

Bergamo, 20147, Italy

Location

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

Bergamo, 20147, Italy

Location

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

Cagliari, 09100, Italy

Location

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

Lucca, 55100, Italy

Location

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

Palermo, 90127, Italy

Location

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

Palermo, 90129, Italy

Location

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

Pisa, 56126, Italy

Location

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

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Ramipril; Irbesartan

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 29, 2016
• Study Start: June 1, 2009
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (13)