Topics

A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient

2019-11-12 18:25:33 | BioPortfolio

Summary

This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in ESA-naïve subjects who have CKD and are not on dialysis.ESA prior users who have more than 8-week washout period for ESA prior to the first day of investigational product administration will also be eligible for this study provided fulfil all the subject entry criteria.

Description

The study will consist of a 20-week correction period for dosage titration and Hb correction, followed by an 8-week evaluation period for efficacy assessments of corrective treatment. Subjects who respond to efepoetin alfa (defined as an increase in Hb ≥1.0 g/dL versus baseline and Hb level within 10 - 12 g/dL range without blood transfusion during the 28 weeks after the first dose) will be eligible to continue treatment, and will be randomised to receive subcutaneous efepoetin alfa either once every 2W or every 4W for an additional 24-week extension period to assess long-term safety and maintenance effect. Mircera responders will also be allowed to continue the drug during the extension period, receiving it every 4 weeks using the dose equal to twice the previous once-every-two-week dose. The safety data collected will be part of an ongoing pooled analysis of safety data from the efepoetin alfa clinical development program.

Study Design

Conditions

Anaemia Associated With Chronic Kidney Disease

Intervention

efepoetin alfa, Mircera

Status

Not yet recruiting

Source

PT Kalbe Genexine Biologics

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-12T18:25:33-0500

Clinical Trials [2746 Associated Clinical Trials listed on BioPortfolio]

A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are...

A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.

This 2 arm study will assess the efficacy and safety of Mircera in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin...

A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin levels, of Mircera and epoetin alfa, in anemic patients with chronic kid...

A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for the Maintenance Treatment of Anemia in Kidney Transplant Recipients.

This 2 arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic ...

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...

PubMed Articles [8709 Associated PubMed Articles listed on BioPortfolio]

Molidustat for the treatment of renal anaemia in patients with dialysis-dependent chronic kidney disease: design and rationale of three phase III studies.

New medications for anaemia associated with chronic kidney disease (CKD) are desirable, owing to the limitations of erythropoiesis-stimulating agents (ESAs), the current standard of care. Molidustat i...

Molidustat for the treatment of renal anaemia in patients with non-dialysis-dependent chronic kidney disease: design and rationale of two phase III studies.

Anaemia is a common complication of chronic kidney disease (CKD). Owing to the limitations of erythropoiesis-stimulating agents (ESAs), the current standard of care, there is a need to develop new the...

Metabolic Surgery Reduces the Risk of Progression From Chronic Kidney Disease to Kidney Failure.

According to the Chronic Kidney Disease Prognosis Consortium (CKD-PC), 1 in 4 patients age ≥ 65 in North America has some form of chronic kidney disease (CKD), while 3 in 100 will progress to kidney...

Impaired Fasting Glucose and Chronic Kidney Disease, Albuminuria, or Worsening Kidney Function: a Secondary Analysis of the SPRINT.

Diabetes mellitus is a risk factor for the development and progression of chronic kidney disease (CKD). However, the association of prediabetes with adverse kidney outcomes is uncertain.

Chronic kidney disease and new antidiabetic drugs : an overview in 2019.

Diabetic nephropathy is a leading cause of chronic kidney disease and dialysis. We know that a good diabetes control slows the progression of kidney disease, but the risk of hypoglycemia is greater in...

Medical and Biotech [MESH] Definitions

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)

Abnormal enlargement or swelling of a KIDNEY due to dilation of the KIDNEY CALICES and the KIDNEY PELVIS. It is often associated with obstruction of the URETER or chronic kidney diseases that prevents normal drainage of urine into the URINARY BLADDER.

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.

A chronic inflammatory condition of the KIDNEY resulting in diffuse renal destruction, a grossly enlarged and nonfunctioning kidney associated with NEPHROLITHIASIS and KIDNEY STONES.

More From BioPortfolio on "A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient"

Quick Search

Relevant Topics

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