Clinical trial NCT02721342: Remission Clinic in Proteinuric Chronic Nephropathies
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Keywords: Chronic proteinuric nephropathies
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.).

Primary outcomes:
measure: Glomerular Filtration Rate (GFR) estimated
timeFrame: Changes from baseline at at least every 3 to 6 months for the duration of the study, an expected average of 10 years.
measure: 24 hour proteinuria
timeFrame: 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:
measure: Number of participants with fatal and non-fatal cardiovascular events
timeFrame: Participants will be followed for the duration of the study, an expected average of 10years.
Other outcomes:
Locations:
city: Ranica
country: Italy
facility: Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò
state: Bergamo
city: Forlì
country: Italy
facility: Ospedale Morgagni - Pierantoni - U.O. Nefrologia e Dialisi
state: Forli'
city: San Gavino- Monreale
country: Italy
facility: Asl 6 Sanluri-P.O. Nostra Signora di Bonaria - U.O. Nefrologia e Dialisi
state: Medio Campidano - VS
city: Ascoli Piceno
country: Italy
facility: Ospedale C.G. Mazzoni Zona 13 ASUR Marche - U.O. Nefrologia e Dialisi
city: Avellino
country: Italy
facility: AORN Moscati - Avellino - U.O. Nefrologia e Dialisi
city: Bergamo
country: Italy
facility: A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi
city: Bergamo
country: Italy
facility: A.O. Papa Giovanni XXIII Bergamo - U.O. Diabetologia
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu - U.O. Nefrologia e Dialisi
city: Lucca
country: Italy
facility: Ospedale Campo di Marte - USL 2 - U.O. Nefrologia
city: Palermo
country: Italy
facility: ARNAS Ospedale Civico Di Cristina Benfratelli - U.O. Nefrologia e Dialisi
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Università degli Studi di Palermo - Dipartimento Malattie Cardiovascolari e Nefrourologiche - U.O. Tecniche Dialitiche
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana - U.O. Nefrologia e Dialisi 2
city: Varese
country: Italy
facility: Ospedale di Circolo Fondazione Macchi - U.O. Nefrologia e Dialisi
Study officials:
References: