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Completed

NCT Number: NCT01306409

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

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

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Key information

Conditions

Renal Anemia Anemia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nephrology and Transplantaton Immunology

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cera, darbepoetin, epoetin-beta

Drug

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

ESA

Drug

Sequential application of three different ESA

Primary outcomes

  1. Reticulocyte count on day 7

    Time frame: day 7

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 1, 2011
Registry last updated
Oct 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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