Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

170

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Sep 2002

Typical duration for phase_3

Geographic Reach

17 countries

63 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

September 1, 2002

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed

1 year until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed

9.7 years until next milestone

Results Posted

Study results publicly available

March 31, 2016

Completed

Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

July 19, 2006

Results QC Date

March 1, 2016

Last Update Submit

March 1, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

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).
Baseline, Month 15

Secondary Outcomes (5)

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

Study Arms (2)

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.

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.

Drug: Epoetin beta

Interventions

Epoetin betaDRUG

Also known as: NeoRecormon

Group 1 (Early Epoetin Beta)Group 2 (No/Late Epoetin Beta)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Hoffmann-La Rochelead

Study Sites (63)

Unknown Facility

Linz, 4020, Austria

Location

Unknown Facility

São Paulo, 04038-002, Brazil

Location

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Jihlava, 586 33, Czechia

Location

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Liberec, 460 63, Czechia

Location

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Copenhagen, 2100, Denmark

Location

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Roskilde, 4000, Denmark

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Jyväskylä, 40620, Finland

Location

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Heidelberg, 69115, Germany

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München, 81675, Germany

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Alexandroupoli, 68100, Greece

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Athens, 11526, Greece

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Ioannina, 45500, Greece

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Nikaia, 18354, Greece

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Thessaloniki, 546 36, Greece

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Thessaloniki, 54629, Greece

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Véria, 59100, Greece

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Budapest, 1076, Hungary

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Budapest, 1115, Hungary

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Miskolc, 3526, Hungary

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Pécs, 7624, Hungary

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Szombathely, 9700, Hungary

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Ancona, 60121, Italy

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Cagliari, 09100, Italy

Location

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Caserta, 81100, Italy

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Cinisello Balsamo, 20092, Italy

Location

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Desio, 20033, Italy

Location

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Lecco, 23900, Italy

Location

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Messina, 98122, Italy

Location

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Milan, 20132, Italy

Location

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Milan, 20162, Italy

Location

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Chihuahua City, 31238, Mexico

Location

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Mexico City, 14000, Mexico

Location

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Monterrey, 64460, Mexico

Location

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Bialystok, 15-540, Poland

Location

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Katowice, 40-027, Poland

Location

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Radom, 26 600, Poland

Location

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Moscow, 109263, Russia

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Moscow, 117036, Russia

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Moscow, 123 448, Russia

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Moscow, 125315, Russia

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Singapore, 169608, Singapore

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A Coruña, 15006, Spain

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Barakaldo, 48903, Spain

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Barcelona, 08907, Spain

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Galdakao, 48960, Spain

Location

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Madrid, 28007, Spain

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Madrid, 28046, Spain

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Valencia, 46017, Spain

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Stockholm, 118 83, Sweden

Location

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Bangkok, 10220, Thailand

Location

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Chiang Mai, 50200, Thailand

Location

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Chon Buri, 20000, Thailand

Location

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Belfast, BT9 7LJ, United Kingdom

Location

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Cambridge, CB2 2QQ, United Kingdom

Location

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London, E1 1BB, United Kingdom

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London, N18 1QX, United Kingdom

Location

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London, SE22 8PT, United Kingdom

Location

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Middlesbrough, TS4 3BW, United Kingdom

Location

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Salford, M6 8HD, United Kingdom

Location

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Sheffield, S57AU, United Kingdom

Location

Unknown Facility

Wrexham, LL13 7TD, United Kingdom

Location

Related Publications (2)

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.
PMID: 36791280DERIVED
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.
PMID: 17261422DERIVED

MeSH Terms

Conditions

Anemia

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title: Medical Communications
Organization: Hoffmann-LaRoche

Study Officials

Ebenhard Ritz, Prof. Dr.
unaffliated
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 20, 2006

Study Start

September 1, 2002

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

March 31, 2016

Results First Posted

March 31, 2016

Record last verified: 2016-03

Locations

IT(9)GB(9)HU(5)SG(1)CZ(2)ME(3)RU(4)TH(5)GR(7)AU(1)PL(3)BR(1)SE(1)DK(2)DE(2)FI(1)ES(7)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Group 1 (Early Epoetin Beta)

Group 2 (No/Late Epoetin Beta)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (63)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations