Kidney Failure, ChronicPhase 3CEDOSENCT00827021

The Clinical Evaluation of the Dose of Erythropoietins Trial

A Phase 3 study testing Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose. in people with Kidney Failure, Chronic, run by Giovanni FM Strippoli, MD at 41 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Failure, Chronic
What is being tested?: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 656 participants
Where: 41 sitesItaly
Study dates: Jul 2009to Jul 2014
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Patients with Hb levels > 10 g/dl without ESAs

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

Italy41 sites

Ospedale Beato Angelo
Acri
Ospedale S. Giovanni Di Dio
Agrigento
Ospedale Civile di Alghero ASL n°1
Alghero
Ospedali Riuniti di Anzio e Nettuno
Anzio
Ospedale Bellaria
Bellaria
Policlinico S. Orsola - Malpighi
Bologna
"A. Perrino" Hospital
Brindisi
Ospedale Maggiore di Chieri ASL TO 5
Chieri
Ospedale Sant'Anna, San Fermo Battaglia
Como
Ospedale Nuovo Sant'Anna
Ferrara
Azienda Ospedaliera Universitaria OO.RR Foggia
Foggia
P.O. SUD - Formia ASL Latina
Formia
Ospedale S. Giovanni di Dio di Gorizia
Gorizia
Jesi (Carlo Urbani)
Iesi
Centro Dialitico Diaverum, Ladispoli
Ladispoli
Ospedale Renzetti ASL Lanciano Vasto
Lanciano
Azienda ospedaliera Ospedale Civile di Legnano
Legnano
Ospedale Fornaroli
Magenta
Ospedale di Manduria
Manduria
Centro Dialitico Diaverum Marsala
Marsala
Ospedale Valle D'Itria ASL TA
Martina Franca
Ospedale di Nicosia
Nicosia
Ospedale San Giacomo
Novi Ligure
Ospedale G. Bernabeo
Ortona
Arnas Civico Di Cristina
Palermo
Azienda Ospedaliera Universitaria di Parma
Parma
Centro di Emodialisi ausl Parma
Parma
Ospedale S. Maria degli Angeli
Pordenone
P.P.I. Priverno
Priverno
Arcispedale S. Maria Nuova, Reggio Emilia
Reggio Emilia
Centro Dialitico Diaverum, Riesi
Riesi
Ospedale S. Barbara
Rogliano
Ospedale S. Eugenio ASL RMC
Roma
Istituto Clinico Humanitas, Rozzano
Rozzano
Policlinico San Donato
San Donato Milanese
Ospedale SS Annunziata
Sassari
Ospedale A.Landolfi
Solofra
Ospedale Alfredo Fiorini di Terracina
Terracina
Azienda Ospedaliera C.T.O./C.R.F./ M. Adelaide
Torino
Ospedale San Giovanni Bosco
Torino
S. Pio da Pietrelcina
Vasto

Other trials in Italy

About this study

Official title: Effects of the Dose of Erythropoiesis Stimulating Agents on Cardiac-cerebrovascular Outcomes Quality of Life and Costs in Hemodialysis Patients. The Clinical Evaluation of the DOSe of Erythropoietins (C.E. DOSE) Trial

The purpose of this study is

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

Read the 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.

Conditions: Kidney Failure, Chronic
Being tested: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.Drug
18000 IU/week I.V. Until the end of the trial

Study groups in NCT00827021
Study group	Role	What they receive
ESAs 1 low dose	Experimental	Not described Receives: Drug: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.
ESAs 2 high dose	Active comparator	Not described Receives: Drug: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.

What is being measured

The primary outcome is the main question the study is designed to answer.

TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein
Measured: after randomization at month 1, 2, 3, 6, 12

Secondary outcomes (10)

Cardiovascular mortality
Measured: after randomization at month 1, 2, 3, 6, 12
sudden death
Measured: after randomization at month 1, 2, 3, 6, 12
Stroke
Measured: after randomization at month 1, 2, 3, 6, 12
myocardial infarction
Measured: after randomization at month 1, 2, 3, 6, 12
hospitalizations due to acute coronary syndrome, transitory ischemic attacks, not planned coronary revascularization, peripheric revascularization.
Measured: after randomization at month 1, 2, 3, 6, 12
Thrombosis of the cardiovascular access
Measured: after randomization at month 1, 2, 3, 6, 12
Seizures
Measured: after randomization at month 1, 2, 3, 6, 12
Hypertensive events
Measured: after randomization at month 1, 2, 3, 6, 12
Quality of life (QoL)
Measured: 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.
Measured: after randomization at month 1, 2, 3, 6, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Jul 2014

First posted22 Jan 2009 (estimated)
Study startJul 2009
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 656 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00827021
Sponsor's protocol ID: FARM6X822T
Other IDs: 2008-006014-20, 2008
Acronym: CEDOSE
Status last verified: Jul 2016
First submitted: 21 Jan 2009
Last updated: 19 Jul 2016
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 20534124
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.
PubMed 23832463

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of the Dose of Erythropoiesis Stimulating Agents on Cardiac-cerebrovascular Outcomes Quality of Life and Costs in Hemodialysis Patients. The Clinical Evaluation of the DOSe of Erythropoietins (C.E. DOSE) Trial
ClinicalTrials.gov ID: NCT00827021
Acronym / sponsor ID: CEDOSE / FARM6X822T
Conditions: Kidney Failure, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 656 participants (actual)
Lead sponsor: Giovanni FM Strippoli, MDUniversity, hospital or other
Study start: Jul 2009
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 22 Jan 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is

the evaluation of biochemical markers to determine the efficacy of individual prediction of ESAs therapy
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:

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

Patients with Hb levels > 10 g/dl without ESAs

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.4000 IU/week I.V. Until the end of the trial	Drug	ESAs 1 low dose
Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.18000 IU/week I.V. Until the end of the trial	Drug	ESAs 2 high dose

Primary outcome

TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein
Time frame: after randomization at month 1, 2, 3, 6, 12

10 secondary outcomes

Cardiovascular mortality
Time frame: after randomization at month 1, 2, 3, 6, 12
sudden death
Time frame: after randomization at month 1, 2, 3, 6, 12
Stroke
Time frame: after randomization at month 1, 2, 3, 6, 12
myocardial infarction
Time frame: after randomization at month 1, 2, 3, 6, 12
hospitalizations due to acute coronary syndrome, transitory ischemic attacks, not planned coronary revascularization, peripheric revascularization.
Time frame: after randomization at month 1, 2, 3, 6, 12
Thrombosis of the cardiovascular access
Time frame: after randomization at month 1, 2, 3, 6, 12
Seizures
Time frame: after randomization at month 1, 2, 3, 6, 12
Hypertensive events
Time frame: after randomization at month 1, 2, 3, 6, 12
Quality of life (QoL)
Time frame: 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.
Time frame: after randomization at month 1, 2, 3, 6, 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
Background: PubMed 20534124Strippoli 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.
Derived from this study: PubMed 23832463Saglimbene 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Giovanni FM Strippoli, MD study chair

Fondazione Mario Negri Sud

41 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein (time frame: after randomization at month 1, 2, 3, 6, 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00827021, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.