- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00476619
Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial (ERIN)
Full Title: A Randomized Controlled Trial of Procrit for the Prevention of Acute Renal Failure in Patients Receiving Intravenous Contrast
Primary Objective: To evaluate the efficacy of a one-time dose of intravenous erythropoietin administration in the prevention or attenuation of contrast-induced acute renal failure.
Secondary Objectives: To evaluate serum and urinary markers of renal injury, including KIM-1, BMP-7, and TGF-b, along with other biomarkers, in subjects receiving intravenous contrast and correlate their expression with clinical outcomes
Study Design: Prospective, multi-centered, randomized, double blind, placebo controlled trial of a one-time dose of EPO. Subjects will be followed for seven days or until hospital discharge, whichever is longer. Total estimated study duration 3 years.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adult subjects with or without diabetes mellitus Eligibility Criteria: undergoing intravenous contrast administration for computerized axial tomography (CAT Scan) as inpatients.
Subjects will be excluded if they have end-stage renal disease (on dialysis or peritoneal dialysis); any known history of acute renal failure; have hemoglobin ³ 12.0 g/dL; history of use of erythropoietin replacement or transfusion within the prior 3 days; use Glucophage/Metformin or Glucovance; are unable to give their written informed consent; have hemodynamic instability; have uncontrolled hypertension; have any history of current malignancy, where current malignancy is defined as subjects undergoing treatment with chemotherapy or radiation therapy, subjects with known metastatic disease, and those with terminal malignant disease; any history of MI, CVA, active angina or unstable angina within the past three months ; are pregnant or lactating; allergic to intravenous contrast, iodine, erythropoietin, mammalian-cell derived products, or human albumin; patients with seizure disorders or have CT scan done as hospital outpatients.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Womens Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects age 18 and over and of either gender.
- Scheduled to receive CT scan with intravenous contrast dye.
- Non diabetics or subjects with type 1 or 2 diabetes mellitus
- Written informed consent.
- Subjects who are on diuretics and non-steroidal inflammatory agents will not be excluded.
- Subjects who have received n-acetylcysteine or sodium bicarbonate pre CT scan will not be excluded
Exclusion Criteria:
- Pregnant or lactating women.
- End-stage renal disease (on hemodialysis or peritoneal dialysis)
- A known history of acute renal failure
- Subjects receiving glucophage/metformin or glucovance
- Subjects who cannot give written informed consent.
- Subjects receiving peritoneal dialysis or hemodialysis.
- Subjects enrolled in another investigational drug study ≤ 30 days of enrollment into the present study.
- Subjects with a known hypersensitivity or anaphylaxis to contrast dye or iodine.
- Subjects with known hypersensitivity or anaphylaxis to erythropoietin, mammalian-cell derived products, or human albumin.
- Age < 18 years
- Use of any erythropoietin replacement or transfusion within the prior 3 days
- Baseline Hemoglobin > 12.0 g/dL
- Uncontrolled hypertension, systolic BP > 180 mmHg or diastolic BP > 110 mmHg in any recording in the past 24 hours.
- Evidence of hemodynamic instability
- Subject unable to follow protocol due to mental incompetence or other reason
- Inaccessibility of medical record
- Subjects with a history of MI, CVA, active angina or unstable angina within the past three months
- Subjects with a history of current malignancy, where current malignancy is defined as subjects undergoing treatment with chemotherapy or radiation therapy, subjects with known metastatic disease, and those with terminal malignant disease.
- Subject with any known history of seizure disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Erythropoeitin
Subjects will receive a one-time dose of either placebo, or EPO 40,000 U intravenously 30 to 240 minutes prior to intravenous contrast administration.
|
Subjects will receive a one-time dose of either placebo, or EPO 40,000 U intravenously 30 to 240 minutes prior to intravenous contrast administration.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of incidence of rise in serum creatinine of 25% or more in the study group vs. placebo
Time Frame: 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Doubling of serum creatinine 2) Need for dialytic support 3) Patient death 4) Comparison of urinary markers of renal injury in subjects in study group vs. placebo and in subjects with and without ARF
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ajay K Singh, M.D., Brigham and Womens Hospital and Harvard Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004P000510
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Contrast Induced Nephropathy
-
Singapore General HospitalActive, not recruitingContrast-induced NephropathySingapore
-
Chinese PLA General HospitalUnknownContrast-induced NephropathyChina
-
Memorial University of NewfoundlandUniversity of AlbertaWithdrawnContrast Induced NephropathyCanada
-
Sun Yat-sen UniversityCompletedContrast Induced NephropathyChina
-
Isfahan University of Medical SciencesUnknownContrast-Induced NephropathyIran, Islamic Republic of
-
Mt. Sinai Medical Center, MiamiFlorida Heart Research InstituteCompleted
-
Kaiser PermanenteCompletedKidney Diseases | Contrast Induced NephropathyUnited States
-
Ospedale Misericordia e DolceCompletedContrast Induced NephropathyItaly
-
Guangdong Provincial People's HospitalGuangdong Medical College; Hainan People's HospitalUnknownContrast Induced NephropathyChina
-
University of ThessalyUnknownContrast Induced Nephropathy
Clinical Trials on erythropoeitin
-
National Institute of Neurological Disorders and...Withdrawn
-
North Texas Veterans Healthcare SystemCompletedAcute Kidney InjuryUnited States
-
SandozHexal AGCompleted