- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01306409
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)
October 18, 2011 updated by: University Hospital, Basel, Switzerland
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents
The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BS
-
Basel, BS, Switzerland, 4031
- Nephrology and Transplantaton Immunology
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- signed informed consent
- age > 18 years, dialysis dependent chronic renal failure
- hemodialysis three times a week
- Kt/V > 1,2 od URR > 65%
- hemoglobin between 11 and 13 g/dl within the last 2 months
- hemoglobin change +/- 1g/dl within the last 4 weeks
- ESA for at least 8 weeks
- Ferritin > 300 ng/ml and Tsat > 25%
Exclusion Criteria:
- Significant bleeding in the last 8 weeks
- blood transfusion within the last 8 weeks
- hemoglobin disorder
- hemolysis
- Malignant disease
- Significant inflammation
- Acute infection
- CRP > 30 mg/l
- Temporary vascular dialysis access
- Vitamin B12 deficiency
- Folic acid deficiency
- Not controlled hyperparathyroidism
- Not controlled hypertension
- Epilepsia within thze last 6 months
- Thrombocyte count > 500 x 10^9 /l
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Sequential application of different ESA
|
Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk
Sequential application of three different ESA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reticulocyte count on day 7
Time Frame: day 7
|
day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael Dickenmann, MD, Transplantation immunology and nephrology, unversity hospital Basel, Switzerland
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
January 1, 2011
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
February 15, 2011
First Submitted That Met QC Criteria
February 28, 2011
First Posted (Estimate)
March 1, 2011
Study Record Updates
Last Update Posted (Estimate)
October 19, 2011
Last Update Submitted That Met QC Criteria
October 18, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 362/09
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.
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