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Sponsored by: |
Affymax |
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Information provided by: | Affymax |
ClinicalTrials.gov Identifier: | NCT00109291 |
To evaluate the safety profile of single intravenous (IV) dose levels of Hematide™ in CKD patients not on dialysis (pre-dialysis patients)
Condition | Intervention | Phase |
---|---|---|
Kidney Diseases |
Drug: Hematide™ Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Single Intravenous Doses of Hematide™ in Patients With Chronic Kidney Disease Who Are Not on Dialysis and Who Have Not Had Prior Erythropoiesis Stimulating Agent (ESA) Treatment |
Enrollment: | 17 |
Study Start Date: | March 2005 |
Study Completion Date: | April 2006 |
Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: Hematide™ |
2: Placebo Comparator | Drug: Placebo |
Up to a maximum of 54 pre-dialysis patients, aged 18-75 years, with hemoglobin ≥ 9 g/dL and ≤ 11 g/dL secondary to chronic kidney disease who have not had previous treatment with ESAs and who meet eligibility criteria will be enrolled in up to 6 dose cohorts (9 patients per cohort, 7 on study drug and 2 on placebo). Patients will be followed through Day 29 or until stabilization of adverse events.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Affymax, Inc. ( Chief Medical Officer ) |
Study ID Numbers: | AFX01-02 |
Study First Received: | April 27, 2005 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00109291 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Chronic Kidney Disease |
Renal Insufficiency Urologic Diseases Hematinics Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Renal Insufficiency Urologic Diseases Hematinics Renal Insufficiency, Chronic Therapeutic Uses |
Hematologic Agents Kidney Failure, Chronic Kidney Diseases Pharmacologic Actions Kidney Failure |