Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia

NCT01543477

Last updated date
Study Location
MHAT "Dr. Tota Venkova"AD
Gabrovo, , 5300, Bulgaria
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Anemia, Pregnancy, Lactation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients currently under treatment with Retacrit™ (epoetin zeta) administered subcutaneously for renal anaemia.

- Informed consent given in writing after being provided with detailed information about the characteristics of this observation by the physician.

- Patients expected to be available for 3 years of observation

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any contraindications as per the current Summary of Product Characteristics (SPC) of
Retacrit™

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Renal Anemia, Pregnancy, LactationPost-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia NCT01543477
  1. Gabrovo,
  2. Montana,
  3. Pleven,
  4. Plovdiv,
  5. Plovdiv,
  6. Smolian,
  7. Sofia,
  8. Sofia,
  9. Sofia,
  10. Sofia,
  11. Sofia,
  12. Sofia,
  13. Varna,
  14. Varna,
  15. Cakovec,
  16. Dubrovnik,
  17. Karlovac,
  18. Labin,
  19. Osijek,
  20. Sibenik,
  21. Umag,
  22. Zagreb,
  23. Zagreb,
  24. Aalborg,
  25. Helsinki,
  26. Jakobstad,
  27. Kajaani,
  28. Amiens (Salouel),
  29. Amiens (Salouel),
  30. Cahors Cedex 9,
  31. Chamallieres,
  32. Clermont Ferrand,
  33. Le Port Marly,
  34. Lille,
  35. Paris Cedex 14,
  36. Paris,
  37. Toulouse Cedex 9,
  38. Alsfeld,
  39. Alsfeld,
  40. Alzey,
  41. Arnstadt,
  42. Bad Bevensen,
  43. Bad Homburg,
  44. Bad König,
  45. Bad Nauheim,
  46. Bad Wildungen,
  47. Berlin,
  48. Berlin,
  49. Berlin,
  50. Berlin,
  51. Darmstadt,
  52. Dormagen,
  53. Essen,
  54. Frankenthal,
  55. Heppenheim,
  56. Herne,
  57. Herzberg,
  58. Homberg/Efze,
  59. Hoyerswerda,
  60. Hürth-Hermülheim,
  61. Kaiserslautern,
  62. Kiel,
  63. Kleve,
  64. Köln,
  65. Langenfeld,
  66. Langenselbold,
  67. Leverkusen,
  68. Ludwigslust,
  69. Luebeck,
  70. Lüdenscheid,
  71. Magdeburg,
  72. Mayen,
  73. Mettmann,
  74. Mühlhausen,
  75. Nettetal,
  76. Neustadt,
  77. Niebüll,
  78. Porrsdam,
  79. Quedlinburg,
  80. Saarlouis,
  81. Solingen,
  82. Tangermünde,
  83. Wiesbaden,
  84. Voula, Attiki
  85. Agioi Apostoloi,
  86. Agios Nikolaos, Crete,
  87. Agrinio,
  88. Aigaleo,
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  90. Athens,
  91. Athens,
  92. Athens,
  93. Athens,
  94. Athens,
  95. Athens,
  96. Athens,
  97. Athens,
  98. Athens,
  99. Athens,
  100. Chania, Crete,
  101. Didimoticho,
  102. Drama,
  103. Edessa,
  104. Filiates,
  105. Grevena,
  106. Kavala,
  107. Komotini,
  108. Kozani,
  109. Kyparissia,
  110. Lamia,
  111. Larisa,
  112. Larisa,
  113. Mesologgi,
  114. Nea Raidestos, Thessaloniki,
  115. Patra,
  116. Ptolemaida,
  117. Serres,
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  128. Volos,
  129. Voula,
  130. Voula,
  131. Galway,
  132. Sant'Angelo dei Lombardi, Avellino
  133. Zingonia- Osio Sotto, Bergamo
  134. Soverato, Catanzaro
  135. Santa Maria Capua Vetere, CE
  136. San Miniato, Pisa
  137. Ancona,
  138. Anzio (RM),
  139. Arezzo,
  140. Ascoli Piceno,
  141. Aversa (NA),
  142. Chieri (TO),
  143. Cona-Ferrara,
  144. Firenze,
  145. Grosseto,
  146. Lido Di Camaiore (Lucca),
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  148. Mestre,
  149. Milano,
  150. Naples,
  151. Napoli,
  152. Napoli,
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  154. Nocera Inferiore (SA),
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  158. PISA (Cisanello),
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  165. Fuenlabrada, Madrid
  166. Benalmadena, Málaga
  167. Xativa, Valencia
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  176. Linköping,
  177. Stockholm,
  178. Stockholm,
  179. London,
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia
Official Title POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)
Brief Summary The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit? (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacrit? (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.
Detailed Description This is a non-interventional, multi-centre, longitudinal observation with a defined population using a prospective cohort design to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit? (epoetin zeta) administered subcutaneously in patients with renal anaemia.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Pre-dose serum samples
Sampling Method Non-Probability Sample
Study Population Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia.
Condition
  • Renal Anemia
  • Pregnancy
  • Lactation
Intervention Not Provided
Study Groups/Cohorts Single group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 8, 2020)
4501
Original Estimated Enrollment
 (submitted: February 27, 2012)
6700
Actual Study Completion Date April 29, 2020
Actual Primary Completion Date April 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients currently under treatment with Retacrit? (epoetin zeta) administered subcutaneously for renal anaemia.
  • Informed consent given in writing after being provided with detailed information about the characteristics of this observation by the physician.
  • Patients expected to be available for 3 years of observation

Exclusion Criteria:

  • Any contraindications as per the current Summary of Product Characteristics (SPC) of Retacrit?
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Bulgaria,   Croatia,   Denmark,   Finland,   France,   Germany,   Greece,   Ireland,   Italy,   Spain,   Sweden,   United Kingdom
Removed Location Countries Portugal
 
Administrative Information
NCT Number NCT01543477
Other Study ID Numbers EPOE-09-11
C1111006 ( Other Identifier: Alias Study Number )
PASCO II ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020