search
Back to results

Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)

Primary Purpose

Renal Anemia

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
cera, darbepoetin, epoetin-beta
ESA
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Renal Anemia focused on measuring anemia, kidney disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nephrology and Transplantaton Immunology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Sequential application of different ESA

Outcomes

Primary Outcome Measures

Reticulocyte count on day 7

Secondary Outcome Measures

Full Information

First Posted
February 15, 2011
Last Updated
October 18, 2011
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Roche Pharma AG
search

1. Study Identification

Unique Protocol Identification Number
NCT01306409
Brief Title
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)
Official Title
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Anemia
Keywords
anemia, kidney disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Sequential application of different ESA
Intervention Type
Drug
Intervention Name(s)
cera, darbepoetin, epoetin-beta
Intervention Description
Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk
Intervention Type
Drug
Intervention Name(s)
ESA
Intervention Description
Sequential application of three different ESA
Primary Outcome Measure Information:
Title
Reticulocyte count on day 7
Time Frame
day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dickenmann, MD
Organizational Affiliation
Transplantation immunology and nephrology, unversity hospital Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology and Transplantaton Immunology
City
Basel
State/Province
BS
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)

We'll reach out to this number within 24 hrs