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Dynepo Infrequent Dosing Study

Primary Purpose

Anemia, Kidney Failure

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dynepo (Epoetin delta)
Dynepo
Dynepo
Dynepo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative [KDOQI] stage III-V).
  • Stable on and taking doses <= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.
  • Transferrin saturation >= 20% and ferritin >= 100 ng/mL.

Exclusion Criteria:

  • Uncontrolled hypertension.
  • Requiring doses of EPO > 10,000 IU/week.
  • Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.
  • Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).
  • Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.
  • Androgen therapy in the 30 days immediately prior to randomisation in the study.
  • Known Human Immunodeficiency Virus(HIV)infection.
  • History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.

Sites / Locations

  • Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse
  • Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie
  • Hopital UCL, Service de Nephrologie
  • UZ Gasthuisberg, Leuve, Dept of Nephrology
  • Hellig Hart Ziekenhuis, Campus Wilgenstraat
  • CHU - Hopital Pellegrin, Nephrologie-Hemodialyse
  • CH de Boulogne-sur-mer (Hopital de Dr Duchenne)
  • Hopital Clemenceau, Nephrologie-Hemodialyse
  • CHU (Centre Hospitalier Universitaire)
  • CHU Hotel Dieu, Service du Pr Soulillou
  • Clinique de Landy, Service de Nephrologie - Hemodialyse
  • Hopital Sud, Service du Pr Fournier
  • CHU Hopital Civil, Nephrologie-Hemodialyse
  • Hopital Rangueil, Service du Pr Durand
  • Hopital Brabois Adultes, Nephrologie
  • Nephrologische Zentrum Villingen-Schwenningen
  • KfH Nierenzebtrum im Linikum Rosenheim
  • KfH Nierenzentrum Bamberg
  • Dialyse-und Apheresezentrum Potsdam-Bebelsberg
  • KfH Nierenzentrum Fulda
  • KfH Nierenzentrum am Handr-Klinikum Stralsund
  • Praxis Dr. Vosskuhler
  • Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich
  • Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe
  • KfK Nierenzentrum Nurnberg
  • Universita' degli Studi di Napoli Federico II
  • Policlinico S. Orsola Malpighi
  • Azienda Ospedaliera Universitaria Policlinico di Modena
  • Azienda Ospedaliera S.Giovanni-Addolorata
  • Spedali Civil Brescia
  • Ospedale Nuovo Alessandro Manzoni
  • Azienda Ospedaliera CTO/CRF/M.Adelaide
  • Ospedali Riuniti
  • A.R.N.A.S Civico Palermo
  • Azienda Sanitaria Locale 4 Area Pratese
  • Hospital Puerto Real
  • Hotel General Universitario
  • Head of Nephrology, Fundacion Puigvert
  • Hospital Vall d'Hebron
  • Hospital Clinic i Provincial
  • Hospital Universitario Reina Sofia
  • Hospital Gregorio Maranon
  • Hospital Central de Asturias
  • Hospital Universitario Marques de Valdecilla
  • Hospital Doctor Peset
  • Hope Hospital
  • Richard Bright Renal Unit Southmead Hospital
  • Addenbrooke's Hospital
  • University Hospital of Wales
  • Glasgow Western Infirmary
  • Kings College Hospital Renal Unit
  • Morrison Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Erythropoietin(EPO)-naive BIW

EPO-naive QW

EPO QW

EPO Q2W

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.

Secondary Outcome Measures

Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Change From Baseline in Hematocrits at 16 and 24 Weeks
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.

Full Information

First Posted
March 21, 2007
Last Updated
June 10, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00450333
Brief Title
Dynepo Infrequent Dosing Study
Official Title
An Open-Label, Phase IIIb, Multi-Centre, Randomised, Parallel-Group Study to Investigate the Efficacy and Safety of Three Dosing Schedules of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease Who Are Pre-Dialysis or Require Peritoneal Dialysis or Haemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA
Study Start Date
October 30, 2006 (Actual)
Primary Completion Date
July 31, 2008 (Actual)
Study Completion Date
July 31, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Kidney Failure
Keywords
Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Erythropoietin(EPO)-naive BIW
Arm Title
2
Arm Type
Active Comparator
Arm Description
EPO-naive QW
Arm Title
3
Arm Type
Active Comparator
Arm Description
EPO QW
Arm Title
4
Arm Type
Active Comparator
Arm Description
EPO Q2W
Intervention Type
Drug
Intervention Name(s)
Dynepo (Epoetin delta)
Intervention Description
subcutaneous, BIW for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Dynepo
Intervention Description
subcutaneous, QW for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Dynepo
Intervention Description
subcutaneous, QW for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Dynepo
Intervention Description
subcutaneous, Q2W for 24 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks
Description
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL
Description
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Time Frame
week 16 and 24
Title
Change From Baseline in Hematocrits at 16 and 24 Weeks
Description
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Time Frame
Baseline and Weeks 16 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative [KDOQI] stage III-V). Stable on and taking doses <= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO. Transferrin saturation >= 20% and ferritin >= 100 ng/mL. Exclusion Criteria: Uncontrolled hypertension. Requiring doses of EPO > 10,000 IU/week. Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study. Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding). Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study. Androgen therapy in the 30 days immediately prior to randomisation in the study. Known Human Immunodeficiency Virus(HIV)infection. History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse
City
Graz
State/Province
Steiemark
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Hopital UCL, Service de Nephrologie
City
Bruxelles
ZIP/Postal Code
B-1200
Country
Belgium
Facility Name
UZ Gasthuisberg, Leuve, Dept of Nephrology
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Hellig Hart Ziekenhuis, Campus Wilgenstraat
City
Roeselare
ZIP/Postal Code
B-8800
Country
Belgium
Facility Name
CHU - Hopital Pellegrin, Nephrologie-Hemodialyse
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
CH de Boulogne-sur-mer (Hopital de Dr Duchenne)
City
Boulogne-sur-mer
ZIP/Postal Code
62321
Country
France
Facility Name
Hopital Clemenceau, Nephrologie-Hemodialyse
City
Caen Cedex 5
ZIP/Postal Code
14033
Country
France
Facility Name
CHU (Centre Hospitalier Universitaire)
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
CHU Hotel Dieu, Service du Pr Soulillou
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Clinique de Landy, Service de Nephrologie - Hemodialyse
City
Saint-Ouen
ZIP/Postal Code
93400
Country
France
Facility Name
Hopital Sud, Service du Pr Fournier
City
Salouel
ZIP/Postal Code
80480
Country
France
Facility Name
CHU Hopital Civil, Nephrologie-Hemodialyse
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Hopital Rangueil, Service du Pr Durand
City
Toulouse Cedex 4
ZIP/Postal Code
31403
Country
France
Facility Name
Hopital Brabois Adultes, Nephrologie
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Nephrologische Zentrum Villingen-Schwenningen
City
Villingen-Schwenningen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
78054
Country
Germany
Facility Name
KfH Nierenzebtrum im Linikum Rosenheim
City
Rosenheim
State/Province
Bavern
ZIP/Postal Code
83022
Country
Germany
Facility Name
KfH Nierenzentrum Bamberg
City
Bamberg
State/Province
Bayern
ZIP/Postal Code
96050
Country
Germany
Facility Name
Dialyse-und Apheresezentrum Potsdam-Bebelsberg
City
Potsdam
State/Province
Brandenburg
ZIP/Postal Code
14482
Country
Germany
Facility Name
KfH Nierenzentrum Fulda
City
Fulda
State/Province
Hessen
ZIP/Postal Code
36043
Country
Germany
Facility Name
KfH Nierenzentrum am Handr-Klinikum Stralsund
City
Stralsund
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18435
Country
Germany
Facility Name
Praxis Dr. Vosskuhler
City
Bottrop
State/Province
Nordrhein Westfalen
ZIP/Postal Code
46242
Country
Germany
Facility Name
Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe
City
Dusseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40210
Country
Germany
Facility Name
KfK Nierenzentrum Nurnberg
City
Nurnberg
ZIP/Postal Code
90471
Country
Germany
Facility Name
Universita' degli Studi di Napoli Federico II
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Policlinico S. Orsola Malpighi
City
Bologna
State/Province
Emilia Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico di Modena
City
Modena
State/Province
Emillia Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
Azienda Ospedaliera S.Giovanni-Addolorata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00184
Country
Italy
Facility Name
Spedali Civil Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Ospedale Nuovo Alessandro Manzoni
City
Lecco
State/Province
Lombardia
ZIP/Postal Code
23900
Country
Italy
Facility Name
Azienda Ospedaliera CTO/CRF/M.Adelaide
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedali Riuniti
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71100
Country
Italy
Facility Name
A.R.N.A.S Civico Palermo
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Sanitaria Locale 4 Area Pratese
City
Prato
State/Province
Toscana
ZIP/Postal Code
59100
Country
Italy
Facility Name
Hospital Puerto Real
City
Puerto Real
State/Province
Cadiz
ZIP/Postal Code
11510
Country
Spain
Facility Name
Hotel General Universitario
City
Castelló de la Plana
State/Province
Castellon
ZIP/Postal Code
120004
Country
Spain
Facility Name
Head of Nephrology, Fundacion Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hope Hospital
City
Salford
State/Province
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Richard Bright Renal Unit Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Glasgow Western Infirmary
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Kings College Hospital Renal Unit
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Morrison Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17999759
Citation
Macdougall IC. Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial. Trials. 2007 Nov 13;8:35. doi: 10.1186/1745-6215-8-35.
Results Reference
derived

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Dynepo Infrequent Dosing Study

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