An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Clinical Evaluation of the Dose of Erythropoietins Trial

NCT00827021

Kidney Failure, Chronic

COMPLETED PHASE3

Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

NCT00236964

Anemia

COMPLETED PHASE3

A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

NCT00144495

Chemotherapy Induced Anemia

COMPLETED PHASE3

Predictors of Response to Iron and Erythropoietin Stimulating Agents

NCT03658876

Renal Failure Chronic Anemia

COMPLETED PHASE4

Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis

NCT00146224

Nephrology

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia of Chronic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ESS

Prescription medical food erythropoietin stimulating system

Group Type EXPERIMENTAL

ESS (medical food/drug)

Intervention Type DRUG

Prescription medical food erythropoietin stimulating system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ESS (medical food/drug)

Prescription medical food erythropoietin stimulating system

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. M/F patients 18 years old and over, non-pregnant/lactating
2. Hemoglobin \< 10 female,\<11 male
3. Ferritin \> upper limit of normal for lab indicative of chronic anemia
4. Anemia of chronic disease
5. Crt. \< 3.0

Exclusion Criteria

1. Currently taking other amino acid formulations.
2. Pregnant or unwilling to use adequate birth control for the duration of the study.
3. Excessive alcohol or illicit drug use.
4. Unwilling or unable to sign informed consent.
5. Myocardial infarction within the last 6 months.
6. Patients ever having taken or currently taking an erythropoietin medication.
7. Iron deficiency (add criteria).
8. On dialysis.
9. Malignancy other than non-melanoma skin cancer within the last 5 years. If has such malignancy, must have documentation of no recurrence for at least 5 years.
10. Liver cirrhosis (add criteria).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No