- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00239616
Pharmacokinetic Study of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
January 22, 2018 updated by: American Regent, Inc.
Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
This is an open-label, multicenter pharmacokinetic study of HD od PD patients receiving erythropoietin.
Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes.
Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.
Study Overview
Detailed Description
This is an open-label, multicenter pharmacokinetic study of HD of adolescent PD patients receiving erythropoietin.
Patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undiluted by slow IV push over 5 minutes, and underwent serial blood draws.
The patients were subsequently followed for 7 days for safety endpoints.
Study Type
Interventional
Enrollment
8
Phase
- Phase 4
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
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 12 and 18
- History of Chronic Renal Failure requiring HD or PD
- Hgb </= 13 g/dL
- Ferritin < 800 ng/ml
- TSAT < 50%
- Receiving EPO
Exclusion Criteria:
- Known Sensitivity to Iron Sucrose
- Severe Concomitant disease of the liver or cardiovascular system
- Serious bacterial Infection
- Pregnancy / Lactation
- Active Hepatitis
- Patients with Causes of iron deficiency other that Chronic Renal Failure
- Blood Transfusion
- Body Weight < 25 KG
- Currently being treated for Asthma
- Received investigational drug within last 30 days
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Pharmacokinetic Parameters
|
Secondary Outcome Measures
Outcome Measure |
---|
Incidence of safety events
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2002
Study Completion
November 1, 2003
Study Registration Dates
First Submitted
October 13, 2005
First Submitted That Met QC Criteria
October 13, 2005
First Posted (Estimate)
October 17, 2005
Study Record Updates
Last Update Posted (Actual)
January 24, 2018
Last Update Submitted That Met QC Criteria
January 22, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1VEN01016
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
-
SanofiActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)United States, Austria, China, Denmark, Germany, Hungary, Italy, Spain, United Kingdom
-
SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)United Kingdom, Belgium, Netherlands, France, United States, Germany, Hungary, Italy
-
Hospital Universitario Dr. Jose E. GonzalezCompletedPernicious Anemia | Megaloblastic Anemia NosMexico
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions
-
Abdelwahed, Mai Mahmoud Mohamed, M.D.UnknownAnemia During PregnancyEgypt
-
University of California, DavisInstituto Mexicano del Seguro Social; Thrasher Research Fund; Mexican National... and other collaboratorsCompleted
-
Incyte CorporationActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)Spain, United States, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, United Kingdom
-
Peking Union Medical College HospitalRecruiting
-
Alexion PharmaceuticalsWithdrawnWarm Autoimmune Hemolytic AnemiaUnited States
Clinical Trials on iron sucrose injection USP
-
Watson PharmaceuticalsCompletedAnemia, Iron-Deficiency | Kidney Failure, ChronicUnited States, Puerto Rico
-
American Regent, Inc.Completed
-
Xinhua Hospital, Shanghai Jiao Tong University...Completed
-
Ruijin HospitalCompletedLung Neoplasm | Segmentectomy;Intersegmental PlaneChina
-
Baxter Healthcare CorporationQuotient SciencesCompletedBioequivalanceUnited States
-
Richard FedorakCompletedIron Deficiency | Inflammatory Bowel DiseaseCanada
-
Peking Union Medical College HospitalUnknownAnemia, Iron DeficiencyChina
-
CN NGANOU-GNINDJIO, MD, MScCompletedIron Deficiency | Chronic Heart Failure (CHF)Cameroon
-
Assiut UniversityUnknownIron Deficiency Anemia
-
American Regent, Inc.Completed