The Clinical Evaluation of the Dose of Erythropoietins Trial

NCT00827021 | Completed Phase 3 DMC

• 2 other identifiers: FARM6X822T2008-006014-20
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 41

Brief Summary

Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESAs) are the most used treatment option. The purpose of this study is

1. 1.the evaluation of biochemical markers to determine the efficacy of individual prediction of ESAs therapy
2. 2.to determine the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein

  after randomization at month 1, 2, 3, 6, 12

Secondary Outcomes (10)

• Cardiovascular mortality

  after randomization at month 1, 2, 3, 6, 12

• sudden death

  after randomization at month 1, 2, 3, 6, 12

• Stroke

  after randomization at month 1, 2, 3, 6, 12

• myocardial infarction

  after randomization at month 1, 2, 3, 6, 12

• hospitalizations due to acute coronary syndrome, transitory ischemic attacks, not planned coronary revascularization, peripheric revascularization.

  after randomization at month 1, 2, 3, 6, 12

Study Arms (2)

ESAs 1 low dose

EXPERIMENTAL

Drug: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.

ESAs 2 high dose

ACTIVE COMPARATOR

Drug: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.

Interventions

Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose. DRUG

4000 IU/week I.V. Until the end of the trial

ESAs 1 low dose

Eligibility Criteria

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

You may qualify if:

• Age \> = 18,
• End stage kidney disease and anemia
• Treatment with hemodialysis for renal replacement therapy
• no contraindications to erythropoietin stimulating agents (ESAs) or already treated with ESAs

You may not qualify if:

• Patients with Hb levels \> 10 g/dl without ESAs

Sponsors & Collaborators

• Giovanni FM Strippoli, MD: lead

Study Sites (41)

Ospedale Beato Angelo

Acri, Italy

Location

Ospedale S. Giovanni Di Dio

Agrigento, Italy

Location

Ospedale Civile di Alghero ASL n°1

Alghero, Italy

Location

Ospedali Riuniti di Anzio e Nettuno

Anzio, Italy

Location

Ospedale Bellaria

Bellaria, Italy

Location

Policlinico S. Orsola - Malpighi

Bologna, Italy

Location

"A. Perrino" Hospital

Brindisi, Italy

Location

Ospedale Maggiore di Chieri ASL TO 5

Chieri, Italy

Location

Ospedale Sant'Anna, San Fermo Battaglia

Como, Italy

Location

Ospedale Nuovo Sant'Anna

Ferrara, Italy

Location

Azienda Ospedaliera Universitaria OO.RR Foggia

Foggia, Italy

Location

P.O. SUD - Formia ASL Latina

Formia, Italy

Location

Ospedale S. Giovanni di Dio di Gorizia

Gorizia, Italy

Location

Jesi (Carlo Urbani)

Iesi, Italy

Location

Centro Dialitico Diaverum, Ladispoli

Ladispoli, Italy

Location

Ospedale Renzetti ASL Lanciano Vasto

Lanciano, Italy

Location

Azienda ospedaliera Ospedale Civile di Legnano

Legnano, Italy

Location

Ospedale Fornaroli

Magenta, Italy

Location

Ospedale di Manduria

Manduria, Italy

Location

Centro Dialitico Diaverum Marsala

Marsala, Italy

Location

Ospedale Valle D'Itria ASL TA

Martina Franca, Italy

Location

Ospedale di Nicosia

Nicosia, Italy

Location

Ospedale San Giacomo

Novi Ligure, Italy

Location

Ospedale G. Bernabeo

Ortona, Italy

Location

Arnas Civico Di Cristina

Palermo, Italy

Location

Azienda Ospedaliera Universitaria di Parma

Parma, Italy

Location

Centro di Emodialisi ausl Parma

Parma, Italy

Location

Ospedale S. Maria degli Angeli

Pordenone, Italy

Location

P.P.I. Priverno

Priverno, Italy

Location

Arcispedale S. Maria Nuova, Reggio Emilia

Reggio Emilia, Italy

Location

Centro Dialitico Diaverum, Riesi

Riesi, Italy

Location

Ospedale S. Barbara

Rogliano, Italy

Location

Ospedale S. Eugenio ASL RMC

Roma, Italy

Location

Istituto Clinico Humanitas, Rozzano

Rozzano, Italy

Location

Policlinico San Donato

San Donato Milanese, Italy

Location

Ospedale SS Annunziata

Sassari, Italy

Location

Ospedale A.Landolfi

Solofra, Italy

Location

Ospedale Alfredo Fiorini di Terracina

Terracina, Italy

Location

Azienda Ospedaliera C.T.O./C.R.F./ M. Adelaide

Torino, Italy

Location

Ospedale San Giovanni Bosco

Torino, Italy

Location

S. Pio da Pietrelcina

Vasto, Italy

Location

Related Publications (2)

• Strippoli GF; Clinical Evaluation of the DOse of Erythropoietins Study Group (C.E. DOSE). Effects of the dose of erythropoiesis stimulating agents on cardiovascular events, quality of life, and health-related costs in hemodialysis patients: the clinical evaluation of the dose of erythropoietins (C.E. DOSE) trial protocol. Trials. 2010 Jun 9;11:70. doi: 10.1186/1745-6215-11-70.

  PMID: 20534124 BACKGROUND

• Saglimbene V, D'Alonzo D, Ruospo M, Vecchio M, Natale P, Gargano L, Nicolucci A, Pellegrini F, Craig JC, Triolo G, Procaccini DA, Santoro A, Di Giulio S, La Rosa S, Murgo A, Di Toro Mammarella R, Sambati M, D'Ambrosio N, Greco V, Giannoccaro G, Flammini A, Boccia E, Montalto G, Pagano S, Amaru S, Fici M, Lumaga GB, Mancini E, Veronesi M, Patregnani L, Querques M, Schiavone P, Chimienti S, Palumbo R, Di Franco D, Della Volpe M, Gori E, Salomone M, Iacono A, Moscoloni M, Treglia A, Casu D, Piras AM, Di Silva A, Mandreoli M, Lopez A, Quarello F, Catizone L, Russo G, Forcellini S, Maccarone M, Catucci G, Di Paolo B, Stingone A, D'Angelo B, Guastoni C, Pasquali S, Minoretti C, Bellasi A, Boscutti G, Martone M, David S, Schito F, Urban L, Di Iorio B, Caruso F, Mazzoni A, Musacchio R, Andreoli D, Cossu M, Li Cavoli G, Cornacchiari M, Granata A, Clementi A, Giordano R, Guastoni C, Barzaghi W, Valentini M, Hegbrant J, Tognoni G, Strippoli GF. [Effects of dose of erythropoiesis stimulating agents on cardiovascular outcomes, quality of life and costs of haemodialysis. the clinical evaluation of the DOSe of erythropoietins (C.E. DOSE) Trial]. G Ital Nefrol. 2013 Mar-Apr;30(2):gin/30.2.21. Italian.

  PMID: 23832463 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Hematinics

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Giovanni FM Strippoli, MD

  Fondazione Mario Negri Sud

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

IT (41)