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A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia

26 octobre 2016 mis à jour par: Hoffmann-La Roche

An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Intravenous Epoetin Alfa to Maintenance Treatment With Intravenous RO0503821 in Hemodialysis Patients With Chronic Renal Anemia.

This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

91

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35211
    • California
      • Los Angeles, California, États-Unis, 90095
    • Illinois
      • Maywood, Illinois, États-Unis, 60153
    • Kentucky
      • Louisville, Kentucky, États-Unis, 40202-1718
    • Michigan
      • Detroit, Michigan, États-Unis, 48236
      • Detroit, Michigan, États-Unis, 48202-2689
    • Minnesota
      • Brooklyn Center, Minnesota, États-Unis, 55430
    • Nevada
      • Las Vegas, Nevada, États-Unis, 89106
    • New Jersey
      • Paterson, New Jersey, États-Unis, 07503
    • New York
      • Brooklyn, New York, États-Unis, 11203
      • Mineola, New York, États-Unis, 11501
      • New York, New York, États-Unis, 10128
    • Tennessee
      • Nashville, Tennessee, États-Unis, 37232
    • West Virginia
      • Morgantown, West Virginia, États-Unis, 26506

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • on hemodialysis therapy for at least 3 months;
  • receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Exclusion Criteria:

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cohort 1 (RO0503821 [0.25/150 1x/week])
Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Médicament: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration
Expérimental: Cohort 2 (RO0503821 [0.25/150 1x/2week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Médicament: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration
Expérimental: Cohort 3 (RO0503821 [0.4/150 1x/week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Médicament: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration
Expérimental: Cohort 4 (RO0503821 [0.4/150 1x/2week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Médicament: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration
Expérimental: Cohort 5 (RO0503821 [0.6/150 1x/week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Médicament: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration
Expérimental: Cohort 6 (RO0503821 [0.6/150 1x/2week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Médicament: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
Délai: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
Délai: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
Délai: Up to Week 126
An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. ). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.
Up to Week 126
Number of Participants With Marked Laboratory Abnormalities
Délai: Up to Week 126
Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10^9/L), Platelets (100 - 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 - 220 U/L), Aspartate aminotransferase (ASAT) (0 - 80 U/L), Albumin >= 30 g/L, Phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], Potassium (2.9 - 5.8 mmol/L), Glucose (2.80 - 11.10 mmol/L).
Up to Week 126
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
Délai: From Baseline (Day -28 to Day 1) to Week 126
Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1).
From Baseline (Day -28 to Day 1) to Week 126
Mean Change in Pulse Rate
Délai: Up to Week 126
Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported.
Up to Week 126

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2002

Achèvement primaire (Réel)

1 juin 2005

Achèvement de l'étude (Réel)

1 juin 2005

Dates d'inscription aux études

Première soumission

24 octobre 2002

Première soumission répondant aux critères de contrôle qualité

24 octobre 2002

Première publication (Estimation)

25 octobre 2002

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

20 décembre 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 octobre 2016

Dernière vérification

1 octobre 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BA16285

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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