Advertisement

Topics

Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects

2014-08-27 03:15:17 | BioPortfolio

Summary

A study to see how a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese compares with a single subcutaneous dose of Epoetin beta (NeoRecormon®) in Caucasian Male subjects. Each subject received a single subcutaneous dose of 50IU/kg of NeoRecormon Multidose solution on Day 1.

Description

Ethnic comparison studies are becoming common research requirements in order to identify differences in response to drugs in various ethnic populations. This study will investigate the pharmacokinetic parameters and pharmacodynamic response in healthy Caucasian and Japanese male subjects after a single subcutaneous administration of 50IU/kg Epoetin beta

This is a Phase I single centre, open label trial to investigate the bioequivalence of a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese and Caucasian Male subjects.

The primary objectives are 1) to establish the pharmacokinetic parameters of Epoetin beta in healthy Japanese and Caucasian males, and 2) to compare the pharmacokinetic parameters AUCinf and Cmax in healthy Japanese and Caucasian males. The secondary objective is to establish the pharmacodynamic parameters of a single dose of Epoetin beta in healthy Japanese and Caucasian males.

Subjects will receive a single subcutaneous administration of 50IU/kg on one occasion only. The planned study duration is approximately 1 month.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Chronic Kidney Failure

Intervention

Epoetin Beta

Status

Completed

Source

InCROM Europe Clinical Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:17-0400

Clinical Trials [3556 Associated Clinical Trials listed on BioPortfolio]

Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.

The Clinical Evaluation of the Dose of Erythropoietins Trial

Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESAs) are the ...

A Study of Once Monthly Intravenous or Subcutaneous Mircera in Patients With Chronic Kidney Disease on Hemodialysis.

This 2 arm study will compare the hemoglobin maintenance with once monthly Mircera administration versus epoetin beta or darbepoetin alfa in patients with chronic kidney disease on hemodia...

An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant

This observational study will investigate efficacy and safety of methoxy polyethyleneglycol-epoetin beta in participants with a kidney transplant. Data of each participant will be collecte...

COMETE Study: Comorbidity Mircera Evolution of Hemoglobin Rate; A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease

This prospective, multicenter, observational study will evaluate the impact of c omorbidity factors on the hemoglobin level in patients with chronic kidney disea se not on dialysis who are...

PubMed Articles [12572 Associated PubMed Articles listed on BioPortfolio]

Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients.

Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III ...

Effect of achieved hemoglobin level on renal outcome in non-dialysis chronic kidney disease (CKD) patients receiving epoetin beta pegol: MIRcerA CLinical Evidence on Renal Survival in CKD patients with renal anemia (MIRACLE-CKD Study).

Previous randomized-controlled trials have shown that targeting higher hemoglobin (Hb) levels using high dose of ESA in non-dialysis chronic kidney disease (NDCKD) patients resulted in poorer cardiova...

Kidney Response to Heart Failure: Proteomic Analysis of Cardiorenal Syndrome.

Chronic heart failure (HF) disrupts normal kidney function and leads to cardiorenal syndrome that further promotes HF progression. To identify potential participants in HF-related injury, we analyzed ...

Perceived Benefits and Challenges of a Risk-Based Approach to Multidisciplinary Chronic Kidney Disease Care: A Qualitative Descriptive Study.

The kidney failure risk equation (KFRE) provides an estimate of risk of progression to kidney failure, and may guide clinical care.

Beraprost Sodium, a Stable Analogue of PGI2, Inhibits the Renin-Angiotensin System in the Renal Tissues of Rats with Chronic Renal Failure.

Chronic renal failure (CRF) is a prolonged kidney condition characterized by decreased kidney function that can eventually develop into total kidney failure. The renin-angiotensin system (RAS) helps t...

Medical and Biotech [MESH] Definitions

A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.

The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.

Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)

A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.

This recombinant erythropoietin, a 165-amino acid glycoprotein (about 62% protein and 38% carbohydrate), regulates red blood cell production. Epoetin alfa is produced by Chinese hamster ovary cells into which the human erythropoietin gene has been inserted. (USP Dictionary of USAN and International Drug Names, 1996).

More From BioPortfolio on "Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...


Searches Linking to this Trial