NCT01306409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 19, 2011

Status Verified

October 1, 2011

Enrollment Period

6 months

First QC Date

February 15, 2011

Last Update Submit

October 18, 2011

Conditions

Renal Anemia

Keywords

anemiakidney disease

Outcome Measures

Primary Outcomes (1)

  • Reticulocyte count on day 7

    day 7

Study Arms (1)

A

EXPERIMENTAL

Sequential application of different ESA

Drug: cera, darbepoetin, epoetin-betaDrug: ESA

Interventions

cera, darbepoetin, epoetin-betaDRUG

Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk

A
ESADRUG

Sequential application of three different ESA

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology and Transplantaton Immunology

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PMID: 36791280DERIVED

MeSH Terms

Conditions

AnemiaKidney Diseases

Interventions

continuous erythropoietin receptor activatorDarbepoetin alfaepoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Michael Dickenmann, MD

    Transplantation immunology and nephrology, unversity hospital Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2011

First Posted

March 1, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

October 19, 2011

Record last verified: 2011-10

Locations

CH(1)