AnemiaPhase 3NCT00354341

(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy

A Phase 3 study testing Epoetin beta in people with Anemia, run by Hoffmann-La Roche at 63 sites in 17 countries.

Completed

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

Trial summary

This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia
What is being tested?: Epoetin beta
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 63 sitesin 17 countries
Study dates: Sep 2002to Jul 2005
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

adult patients >=18 years of age;
type 1 or type 2 diabetes;
stable glycemic control for >=3 months;
diabetic nephropathy.

Who cannot join

women who are pregnant, breastfeeding, or unwilling to use a reliable contraceptive method;
previous treatment with erythropoietin or other erythropoietic substance;
nondiabetic renal disease, nephrotic syndrome;
blood transfusion within the 3 months prior to enrollment;
administration of any investigational drug within 30 days preceding the study start, and during the study.

Trial locations and contacts

63 sites in 17 countries.

Country

City, postcode or hospital

63 sites in 17 countries

Italy9 sites

Study site
Ancona, 60121
Study site
Cagliari, 09100
Study site
Caserta, 81100
Study site
Cinisello Balsamo, 20092
Study site
Desio, 20033
Study site
Lecco, 23900
Study site
Messina, 98122
Study site
Milan, 20132
Study site
Milan, 20162

Other trials in Italy

United Kingdom9 sites

Study site
Belfast, BT9 7LJ
Study site
Cambridge, CB2 2QQ
Study site
London, E1 1BB
Study site
London, N18 1QX
Study site
London, SE22 8PT
Study site
Middlesbrough, TS4 3BW
Study site
Salford, M6 8HD
Study site
Sheffield, S57AU
Study site
Wrexham, LL13 7TD

Other trials in United Kingdom

Greece7 sites

Study site
Alexandroupoli, 68100
Study site
Athens, 11526
Study site
Ioannina, 45500
Study site
Nikaia, 18354
Study site
Thessaloniki, 546 36
Study site
Thessaloniki, 54629
Study site
Véria, 59100

Other trials in Greece

Spain7 sites

Study site
A Coruña, 15006
Study site
Barakaldo, 48903
Study site
Barcelona, 08907
Study site
Galdakao, 48960
Study site
Madrid, 28007
Study site
Madrid, 28046
Study site
Valencia, 46017

Other trials in Spain

Hungary5 sites

Study site
Budapest, 1076
Study site
Budapest, 1115
Study site
Miskolc, 3526
Study site
Pécs, 7624
Study site
Szombathely, 9700

Other trials in Hungary

Thailand5 sites

Study site
Bangkok, 10220
Study site
Bangkok, 10330
Study site
Bangkok, 10400
Study site
Chiang Mai, 50200
Study site
Chon Buri, 20000

Other trials in Thailand

Russia4 sites

Study site
Moscow, 109263
Study site
Moscow, 117036
Study site
Moscow, 123 448
Study site
Moscow, 125315

Other trials in Russia

Mexico3 sites

Study site
Chihuahua City, 31238
Study site
Mexico City, 14000
Study site
Monterrey, 64460

Other trials in Mexico

Poland3 sites

Study site
Bialystok, 15-540
Study site
Katowice, 40-027
Study site
Radom, 26 600

Other trials in Poland

Czechia2 sites

Study site
Jihlava, 586 33
Study site
Liberec, 460 63

Other trials in Czechia

Denmark2 sites

Study site
Copenhagen, 2100
Study site
Roskilde, 4000

Other trials in Denmark

Germany2 sites

Study site
Heidelberg, 69115
Study site
München, 81675

Other trials in Germany

Austria1 site

Study site
Linz, 4020

Other trials in Austria

Brazil1 site

Study site
São Paulo, 04038-002

Other trials in Brazil

Finland1 site

Study site
Jyväskylä, 40620

Other trials in Finland

Singapore1 site

Study site
Singapore, 169608

Other trials in Singapore

Sweden1 site

Study site
Stockholm, 118 83

Other trials in Sweden

About this study

Official title: An Open, Randomized, Multi-centre Trial to Investigate the Effect of Anemia Correction on Cardiac Structure and Function in Patients With Early Diabetic Nephropathy

Conditions: Anemia
Being tested: Epoetin beta
Medical subject headings: Anemia

What participants receive

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

Epoetin betaDrug
Also called NeoRecormon

Study groups in NCT00354341
Study group	Role	What they receive
Group 1 (Early Epoetin Beta)	Experimental	Along with their standard treatment participants will receive epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses will be adjusted according to individual participant's Hb level. Standard treatment will be as per investigator discretion. Receives: Drug: Epoetin beta
Group 2 (No/Late Epoetin Beta)	Active comparator	Participants will receive their standard treatment for 15 months but no treatment for anemia correction unless Hb level will be less than (<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level will be <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment will be as per investigator discretion. Receives: Drug: Epoetin beta

What is being measured

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

Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15
LVMI (in g/m^2) = (0.8 [1.04 {(LVEDD + IVS + PWT)^3 - (LVEDD)^3}] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters [cm]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m^2).
Measured: Baseline, Month 15

Secondary outcomes (5)

Left Ventricular End Systolic Volume Index (LVESVI)
LVESVI was calculated by dividing left ventricular end systolic volume (LVESV) (in milliliters [mL]) with body surface area (BSA) (in meter square [m^2]). LVESVI is presented in milliliter per meter square (mL/m^2).
Measured: Baseline, Months 6 and 15
Left Ventricular End Diastolic Volume Index (LVEDVI)
LVEDVI was calculated by dividing left ventricular end diastolic volume (LVEDV) (in mL) BSA (in m^2). LVEDVI was presented in mL/m^2.
Measured: Baseline, Months 6 and 15
Fractional Myocardial Shortening (FS)
FS was calculated as: ([LVEDD - LVESD] divided by LVEDV) multiplied by 100; where LVEDD = left ventricular end diastolic diameter (in centimeters [cm]), LVESD = left ventricular end systolic diameter (in cm), LVEDV = left ventricular end diastolic volume (in mL). FS is expressed in percentage of LVEDV.
Measured: Baseline, Months 6 and 15
Left Ventricular Ejection Fraction (LVEF)
LVEF was calculated as ([LVEDV - LVESV], divided by LVEDV) multiplied by 100; where LVEDV = left ventricular end diastolic volume (in mL), LVESV = left ventricular end systolic volume (in mL). LVEF is expressed in percentage of LVEDV.
Measured: Baseline, Months 6 and 15
Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL
Measured: Week 26 up to Week 64

Timeline

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

Sep 2002Jul 2005

First posted20 Jul 2006 (estimated)
Study startSep 2002
Primary completionJul 2005
Study completionJul 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AnemiaStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
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: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00354341
Sponsor's protocol ID: MA16620
Status last verified: Mar 2016
First submitted: 19 Jul 2006
Last updated: 31 Mar 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280
Ritz E, Laville M, Bilous RW, O'Donoghue D, Scherhag A, Burger U, de Alvaro F; Anemia Correction in Diabetes Study Investigators. Target level for hemoglobin correction in patients with diabetes and CKD: primary results of the Anemia Correction in Diabetes (ACORD) Study. Am J Kidney Dis. 2007 Feb;49(2):194-207. doi: 10.1053/j.ajkd.2006.11.032.
PubMed 17261422

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?

See locations

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Randomized, Multi-centre Trial to Investigate the Effect of Anemia Correction on Cardiac Structure and Function in Patients With Early Diabetic Nephropathy
ClinicalTrials.gov ID: NCT00354341
Acronym / sponsor ID: MA16620
Conditions: Anemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Sep 2002
Primary completion: Jul 2005 (actual)
Study completion: Jul 2005 (actual)
First posted: 20 Jul 2006 (estimated)
Results: Posted 31 Mar 2016

Clinical summary

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

Study design

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

Arm	Type	Receives
Group 1 (Early Epoetin Beta)	Experimental	Drug: Epoetin betaAlong with their standard treatment participants will receive epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses will be adjusted according to individual participant's Hb level. Standard treatment will be as per investigator discretion.
Group 2 (No/Late Epoetin Beta)	Active comparator	Drug: Epoetin betaParticipants will receive their standard treatment for 15 months but no treatment for anemia correction unless Hb level will be less than (<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level will be <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment will be as per investigator discretion.

Who may qualify

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

Key inclusion criteria (4 listed)

adult patients >=18 years of age;
type 1 or type 2 diabetes;
stable glycemic control for >=3 months;
diabetic nephropathy.

Key exclusion criteria (5 listed)

women who are pregnant, breastfeeding, or unwilling to use a reliable contraceptive method;
previous treatment with erythropoietin or other erythropoietic substance;
nondiabetic renal disease, nephrotic syndrome;
blood transfusion within the 3 months prior to enrollment;
administration of any investigational drug within 30 days preceding the study start, and during the study.

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
Epoetin betaAlso: NeoRecormon	Drug	Group 1 (Early Epoetin Beta), Group 2 (No/Late Epoetin Beta)

Primary outcome

Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15
Time frame: Baseline, Month 15
LVMI (in g/m^2) = (0.8 [1.04 {(LVEDD + IVS + PWT)^3 - (LVEDD)^3}] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters [cm]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m^2).

5 secondary outcomes

Left Ventricular End Systolic Volume Index (LVESVI)
Time frame: Baseline, Months 6 and 15
Left Ventricular End Diastolic Volume Index (LVEDVI)
Time frame: Baseline, Months 6 and 15
Fractional Myocardial Shortening (FS)
Time frame: Baseline, Months 6 and 15
Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline, Months 6 and 15
Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL
Time frame: Week 26 up to Week 64

Results and safety

Results posted to the registry on 31 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (Early Epoetin Beta)	88	85
Group 2 (No/Late Epoetin Beta)	82	75

Primary outcome: Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15

Time frame: Baseline, Month 15. Mean (Standard Deviation). Unit: g/m^2

Measure	Group 1 (Early Epoetin Beta) n = 84	Group 2 (No/Late Epoetin Beta) n = 79
Value	0.69 (26.34)	0.10 (24.25)

Group 1 (Early Epoetin Beta) vs Group 2 (No/Late Epoetin Beta): p = 0.8811, ANCOVA with LOCF

Population analysed: ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 30 days after last study drug administration (35 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (Early Epoetin Beta)	21 of 88 (23.9%)	21 of 88 (23.9%)	Not reported
Group 2 (No/Late Epoetin Beta)	20 of 82 (24.4%)	17 of 82 (20.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
Derived from this study: PubMed 17261422Ritz E, Laville M, Bilous RW, O'Donoghue D, Scherhag A, Burger U, de Alvaro F; Anemia Correction in Diabetes Study Investigators. Target level for hemoglobin correction in patients with diabetes and CKD: primary results of the Anemia Correction in Diabetes (ACORD) Study. Am J Kidney Dis. 2007 Feb;49(2):194-207. doi: 10.1053/j.ajkd.2006.11.032.

Related trials for Anemia

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

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.

Ebenhard Ritz, Prof. Dr. principal investigator

unaffliated

63 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epoetin beta in people with Anemia, run by Hoffmann-La Roche at 63 sites in 17 countries.

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 5 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 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Italy, United Kingdom, Greece, Spain, Hungary and 12 more countries. 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?

Yes. Results are posted in the registry (first posted 31 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 (time frame: Baseline, Month 15). 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 NCT00354341, 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 31 Mar 2016.