Fixed Dose NESP Study in Subjects With CRI

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2002-02-28

Brief Summary

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

Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time blood will be drawn and vital signs will be taken. Upon enrollment, subjects will receive SC darbepoetin alfa administered once every other week for 24 weeks. Darbepoetin alfa will be titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. During the study, laboratory assessments will be completed and vital signs will be taken. Subjects will enter a 1-week post-treatment observation and evaluation period after the last dose of study drug.

Related Clinical Trials

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

A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis

NCT00750295

Chronic Kidney Disease

COMPLETED PHASE1/PHASE2

A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment

NCT04859439

Renal Impairment

COMPLETED PHASE1

CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis

NCT03428594

Anemia of Chronic Kidney Disease

COMPLETED PHASE3

A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants With Varying Degrees of Renal Function

NCT03546205

Kidney Failure, Chronic

COMPLETED PHASE1

Safety Study of GCS-100 to Treat Chronic Kidney Disease

NCT01717248

Chronic Kidney Disease

COMPLETED PHASE1

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.

Pre-Dialysis

Study Design

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

Allocation Method

NON_RANDOMIZED

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.

darbepoetin alfa

darbepoetin alfa (NESP)

Group Type EXPERIMENTAL

darbepoetin alfa

Intervention Type DRUG

10 mcg NESP administered SC every other week 15 mcg NESP administered SC every other week 20 mcg NESP administered SC every other week 30 mcg NESP administered SC every other week 40 mcg NESP administered SC every other week 50 mcg NESP administered SC every other week 60 mcg NESP administered SC every other week 80 mcg NESP administered SC every other week 100 mcg NESP administered SC every other week

Interventions

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

darbepoetin alfa

10 mcg NESP administered SC every other week 15 mcg NESP administered SC every other week 20 mcg NESP administered SC every other week 30 mcg NESP administered SC every other week 40 mcg NESP administered SC every other week 50 mcg NESP administered SC every other week 60 mcg NESP administered SC every other week 80 mcg NESP administered SC every other week 100 mcg NESP administered SC every other week

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Greater than or equal to 18 years of age
* CRI with a creatinine clearance of less than 40 mL/min
* Hemoglobin less than 11.0 g/dL
* Serum vitamin B12 and folate levels above the lower limit of normal and iron replete

Exclusion Criteria

* Received rHuEPO therapy in the last 12 weeks
* Expected to initiate renal replacement therapy within 24 weeks or a recipient of a renal transplant
* Uncontrolled hypertension
* Seizure activity, CHF, hyperparathyroidism, major surgery, HIV-positive Pregnant or breast-feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No