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An Extension Study to Evaluate the Safety and Tolerability of Hematide™ for the Long-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease (CKD)
This study is ongoing, but not recruiting participants.
First Received: March 27, 2007   Last Updated: May 14, 2009   History of Changes
Sponsored by: Affymax
Information provided by: Affymax
ClinicalTrials.gov Identifier: NCT00453973
  Purpose

To evaluate the safety and tolerability of Hematide™ for the maintenance of hemoglobin (Hgb) in patients with Chronic Kidney Disease (CKD).


Condition Intervention Phase
Anemia
Chronic Kidney Disease
Drug: Hematide™
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title: An Open-Label, Multi-Center, Extension Study to Evaluate the Safety and Tolerability of Hematide™ Injection for the Long-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Affymax:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of Hematide™ treatment for the long-term maintenance of Hgb in patients with CKD [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 125
Study Start Date: November 2006
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Hematide™
Injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is informed of the investigational nature of this study and has given written, informed consent in accordance with institutional, local, and national guidelines.
  • Males or females ≥ 18 years of age.
  • Premenopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study drug administration, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug.
  • Patient who has received at least 24 weeks of Hematide™ dosing in a previous Affymax-sponsored study.
  • One Hgb value of ≥ 10.0g/dL in the 4 weeks prior to study drug administration.

Exclusion Criteria:

  • Known intolerance to Hematide™ or PEGylated products.
  • History of antibodies to any erythropoiesis stimulating agent (ESA) or history of pure red cell aplasia (PRCA).
  • High likelihood of early withdrawal or interruption of the study (e.g., patient suffers from any clinically significant medical disease or condition that may, in the Investigator's opinion, interfere with safety, assessment, or follow-up of the patient)
  • Anticipated life expectancy < 18 months
  • Receipt of any ESA other than Hematide™ at any time after patient enrollment in the previous Affymax-sponsored study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453973

Locations
Bulgaria
Research Facility
Varna, Bulgaria, 9010
Research Facility
Rousse, Bulgaria, 7002
Research Facility
Pleven, Bulgaria, 5800
Research Facility
Plovdiv, Bulgaria, 4003
Research Facility
Veliko Tarnovo, Bulgaria, 5000
Research Facility
Burgas, Bulgaria, 8000
Poland
Research Facility
Łódź, Poland, 90-153
Research Facility
Kraków, Poland, 31-501
Research Facility
Białystok, Poland, 15-540
Research Facility
Kraków, Poland, 31-826
Research Facility
Katowice, Poland, 40-027
Romania
Research Facility
Iasi, Romania, 700506
Research Facility
Timisoara, Romania, 300736
Research Facility
Arad, Romania, 310017
Research Facility
Bacau, Romania, 600114
Research Facility
Bucuresti, Romania, 014461
United Kingdom
Research Facility
London, United Kingdom, SES 9RS
Research Facility
London, United Kingdom, SW17 0QT
Research Facility
Croydon, United Kingdom, CR7 7YE
Research Facility
Swansea, United Kingdom, SA6 6NL
Research Facility
London, United Kingdom, E1 1BB
Research Facility
Derby, United Kingdom, DE22 3NE
Sponsors and Collaborators
Affymax
Investigators
Study Director: Chief Medical Officer Affymax, Inc.
  More Information

No publications provided

Responsible Party: Affymax ( Chief Medical Officer )
Study ID Numbers: AFX01-10
Study First Received: March 27, 2007
Last Updated: May 14, 2009
ClinicalTrials.gov Identifier: NCT00453973     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Affymax:
Anemia
Chronic Kidney Disease

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic
Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:
Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Anemia
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 10, 2009