Dynepo Infrequent Dosing Study

June 10, 2021 updated by: Shire

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

407

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie
    • Steiemark
      • Graz, Steiemark, Austria, A-8036
        • Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse
  • Belgium
      • Bruxelles, Belgium, B-1200
        • Hopital UCL, Service de Nephrologie
      • Leuven, Belgium, B-3000
        • UZ Gasthuisberg, Leuve, Dept of Nephrology
      • Roeselare, Belgium, B-8800
        • Hellig Hart Ziekenhuis, Campus Wilgenstraat
  • France
      • Bordeaux Cedex, France, 33076
        • CHU - Hopital Pellegrin, Nephrologie-Hemodialyse
      • Boulogne-sur-mer, France, 62321
        • CH de Boulogne-sur-mer (Hopital de Dr Duchenne)
      • Caen Cedex 5, France, 14033
        • Hopital Clemenceau, Nephrologie-Hemodialyse
      • Grenoble Cedex 9, France, 38043
        • CHU (Centre Hospitalier Universitaire)
      • Nantes Cedex 1, France, 44093
        • CHU Hotel Dieu, Service du Pr Soulillou
      • Saint-Ouen, France, 93400
        • Clinique de Landy, Service de Nephrologie - Hemodialyse
      • Salouel, France, 80480
        • Hopital Sud, Service du Pr Fournier
      • Strasbourg Cedex, France, 67091
        • CHU Hopital Civil, Nephrologie-Hemodialyse
      • Toulouse Cedex 4, France, 31403
        • Hopital Rangueil, Service du Pr Durand
      • Vandoeuvre Les Nancy, France, 54511
        • Hopital Brabois Adultes, Nephrologie
  • Germany
      • Nurnberg, Germany, 90471
        • KfK Nierenzentrum Nurnberg
    • Baden-Wurttemberg
      • Villingen-Schwenningen, Baden-Wurttemberg, Germany, 78054
        • Nephrologische Zentrum Villingen-Schwenningen
    • Bavern
      • Rosenheim, Bavern, Germany, 83022
        • KfH Nierenzebtrum im Linikum Rosenheim
    • Bayern
      • Bamberg, Bayern, Germany, 96050
        • KfH Nierenzentrum Bamberg
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14482
        • Dialyse-und Apheresezentrum Potsdam-Bebelsberg
    • Hessen
      • Fulda, Hessen, Germany, 36043
        • KfH Nierenzentrum Fulda
    • Mecklenburg-Vorpommern
      • Stralsund, Mecklenburg-Vorpommern, Germany, 18435
        • KfH Nierenzentrum am Handr-Klinikum Stralsund
    • Nordrhein Westfalen
      • Bottrop, Nordrhein Westfalen, Germany, 46242
        • Praxis Dr. Vosskuhler
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
        • Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich
      • Dusseldorf, Nordrhein-Westfalen, Germany, 40210
        • Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Universita' Degli Studi Di Napoli Federico Ii
    • Emilia Romagna
      • Bologna, Emilia Romagna, Italy, 40138
        • Policlinico S. Orsola Malpighi
    • Emillia Romagna
      • Modena, Emillia Romagna, Italy, 41100
        • Azienda Ospedaliera Universitaria Policlinico Di Modena
    • Lazio
      • Roma, Lazio, Italy, 00184
        • Azienda Ospedaliera S.Giovanni-Addolorata
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • Spedali Civil Brescia
      • Lecco, Lombardia, Italy, 23900
        • Ospedale Nuovo Alessandro Manzoni
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • Azienda Ospedaliera CTO/CRF/M.Adelaide
    • Puglia
      • Foggia, Puglia, Italy, 71100
        • Ospedali Riuniti
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • A.R.N.A.S Civico Palermo
    • Toscana
      • Prato, Toscana, Italy, 59100
        • Azienda Sanitaria Locale 4 Area Pratese
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Barcelona, Spain, 08025
        • Head of Nephrology, Fundacion Puigvert
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañon
      • Oviedo, Spain, 33006
        • Hospital Central de Asturias
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Valencia, Spain, 46017
        • Hospital Doctor Peset
    • Cadiz
      • Puerto Real, Cadiz, Spain, 11510
        • Hospital Puerto Real
    • Castellon
      • Castelló de la Plana, Castellon, Spain, 120004
        • Hotel General Universitario
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • Richard Bright Renal Unit Southmead Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • Glasgow, United Kingdom, G11 6NT
        • Glasgow Western Infirmary
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital Renal Unit
      • Swansea, United Kingdom, SA6 6NL
        • Morrison Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Hope Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Erythropoietin(EPO)-naive BIW
Drug: Dynepo (Epoetin delta)
subcutaneous, BIW for 24 weeks
Active Comparator: 2
EPO-naive QW
Drug: Dynepo
subcutaneous, QW for 24 weeks
Drug: Dynepo
subcutaneous, Q2W for 24 weeks
Active Comparator: 3
EPO QW
Drug: Dynepo
subcutaneous, QW for 24 weeks
Drug: Dynepo
subcutaneous, Q2W for 24 weeks
Active Comparator: 4
EPO Q2W
Drug: Dynepo
subcutaneous, QW for 24 weeks
Drug: Dynepo
subcutaneous, Q2W for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks
Time Frame: Baseline 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.
Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL
Time Frame: week 16 and 24
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.
week 16 and 24
Change From Baseline in Hematocrits at 16 and 24 Weeks
Time Frame: Baseline and Weeks 16 and 24
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.
Baseline and Weeks 16 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2006

Primary Completion (Actual)

July 31, 2008

Study Completion (Actual)

July 31, 2008

Study Registration Dates

First Submitted

March 21, 2007

First Submitted That Met QC Criteria

March 21, 2007

First Posted (Estimate)

March 22, 2007

Study Record Updates

Last Update Posted (Actual)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 10, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD490-301
  • 2006-002052-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anemia

Clinical Trials on Dynepo (Epoetin delta)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe