The Clinical Evaluation of the Dose of Erythropoietins Trial
- Conditions
- Kidney Failure, Chronic
- Registration Number
- NCT00827021
- Lead Sponsor
- Giovanni FM Strippoli, MD
- 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. the evaluation of biochemical markers to determine the efficacy of individual prediction of ESAs therapy
2. to determine the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).
- Detailed Description
Phase III pragmatic, randomized-controlled trial comparing different doses of ESAs in patients with renal anaemia.
Study Sample:
Total of 900 participants from Italy
Background and Rationale:
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 (ESA) are the most used treatment option. In observational studies higher haemoglobin (Hb) levels (around 10-13 g/dL) are associated with improved survival and quality of life compared to lower Hb levels (around 9 g/dL). Randomized studies have found that higher Hb targets, achieved and maintained with ESA, cause an increased risk of death, mainly due to adverse cardiac-cerebrovascular outcomes. It is possible that such effect is mediated by ESA dose. This hypothesis has not been formally tested and is the aim of the Clinical Evaluation of the DOSe of Erythropoietins (CEDOSE) trial.
CEDOSE is the first independent multicentre trial exploring the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).
Hypothesis:
ESA resistance is associated with adverse vascular outcomes and poor quality of life in ESKD.
The CEDOSE trial will evaluate the biochemical markers to determine the efficacy of individual prediction of ESAs therapy; moreover it will evaluate the benefits and harms of two fixed ESA doses and explore the role of two treatment strategies, one based on a low and one based on a high ESA dose.
Interventions and Comparison:
Patients will be randomized 1:1 to 4000 IU/week iv. versus 18000 IU/week iv. of epoetin alfa, beta or any other epoetin in equivalent doses.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 656
- 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
- Patients with Hb levels > 10 g/dl without ESAs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein after randomization at month 1, 2, 3, 6, 12
- Secondary Outcome Measures
Name Time Method Cardiovascular mortality after randomization at month 1, 2, 3, 6, 12 sudden death 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 Thrombosis of the cardiovascular access after randomization at month 1, 2, 3, 6, 12 Hypertensive events after randomization at month 1, 2, 3, 6, 12 Quality of life (QoL) at randomization and at 6 and 12 months composite of all-cause mortality, non fatal myocardial infarction and stroke, hospitalizations due to acute coronary syndrome, transitory ischaemic attacks, not planned coronary revascularization procedures, peripheric revascularization procedures. after randomization at month 1, 2, 3, 6, 12 Stroke after randomization at month 1, 2, 3, 6, 12 Seizures after randomization at month 1, 2, 3, 6, 12
Trial Locations
- Locations (41)
Ospedale SS Annunziata
🇮🇹Sassari, Italy
Ospedale A.Landolfi
🇮🇹Solofra, Italy
Ospedali Riuniti di Anzio e Nettuno
🇮🇹Anzio, Italy
Ospedale Civile di Alghero ASL n°1
🇮🇹Alghero, Italy
Centro Dialitico Diaverum, Ladispoli
🇮🇹Ladispoli, Italy
Ospedale di Manduria
🇮🇹Manduria, Italy
Ospedale di Nicosia
🇮🇹Nicosia, Italy
Ospedale Beato Angelo
🇮🇹Acri, Italy
Ospedale Sant'Anna, San Fermo Battaglia
🇮🇹Como, Italy
Centro di Emodialisi ausl Parma
🇮🇹Parma, Italy
Jesi (Carlo Urbani)
🇮🇹Jesi, Italy
Ospedale San Giacomo
🇮🇹Novi Ligure, Italy
S. Pio da Pietrelcina
🇮🇹Vasto, Italy
Ospedale S. Giovanni Di Dio
🇮🇹Agrigento, Italy
Ospedale Bellaria
🇮🇹Bellaria, Italy
Ospedale Maggiore di Chieri ASL TO 5
🇮🇹Chieri, Italy
"A. Perrino" Hospital
🇮🇹Brindisi, Italy
Policlinico S. Orsola - Malpighi
🇮🇹Bologna, Italy
P.O. SUD - Formia ASL Latina
🇮🇹Formia, Italy
Ospedale Nuovo Sant'Anna
🇮🇹Ferrara, Italy
Ospedale S. Giovanni di Dio di Gorizia
🇮🇹Gorizia, Italy
Azienda Ospedaliera Universitaria OO.RR Foggia
🇮🇹Foggia, Italy
Ospedale Renzetti ASL Lanciano Vasto
🇮🇹Lanciano, Italy
Azienda ospedaliera Ospedale Civile di Legnano
🇮🇹Legnano, Italy
Ospedale Fornaroli
🇮🇹Magenta, Italy
Centro Dialitico Diaverum Marsala
🇮🇹Marsala, Italy
Ospedale Valle D'Itria ASL TA
🇮🇹Martina Franca, Italy
Ospedale G. Bernabeo
🇮🇹Ortona, Italy
Azienda Ospedaliera Universitaria di Parma
🇮🇹Parma, Italy
Policlinico San Donato
🇮🇹San Donato Milanese, Italy
Ospedale S. Maria degli Angeli
🇮🇹Pordenone, Italy
Arnas Civico Di Cristina
🇮🇹Palermo, Italy
Centro Dialitico Diaverum, Riesi
🇮🇹Riesi, Italy
P.P.I. Priverno
🇮🇹Priverno, Italy
Arcispedale S. Maria Nuova, Reggio Emilia
🇮🇹Reggio Emilia, Italy
Ospedale S. Barbara
🇮🇹Rogliano, Italy
Ospedale S. Eugenio ASL RMC
🇮🇹Roma, Italy
Ospedale Alfredo Fiorini di Terracina
🇮🇹Terracina, Italy
Istituto Clinico Humanitas, Rozzano
🇮🇹Rozzano, Italy
Azienda Ospedaliera C.T.O./C.R.F./ M. Adelaide
🇮🇹Torino, Italy
Ospedale San Giovanni Bosco
🇮🇹Torino, Italy