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Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial (ERIN)

Primary Purpose

Contrast Induced Nephropathy

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

erythropoeitin

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring Contrast, Nephropathy, acute renal failure, Erythropoietin, CT scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brigham and Womens hospital

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

Erythropoeitin

Arm Description

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.

Outcomes

Primary Outcome Measures

Comparison of incidence of rise in serum creatinine of 25% or more in the study group vs. placebo

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00476619

First Posted

May 21, 2007

Last Updated

April 2, 2009

Sponsor

Brigham and Women's Hospital

Collaborators

Ortho Biotech Products, L.P.

1. Study Identification

Unique Protocol Identification Number

NCT00476619

Brief Title

Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial

Acronym

ERIN

Official Title

Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Terminated

Why Stopped

The exclusion criteria were stringent and enrollment was slow.

Study Start Date

September 2004 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

Ortho Biotech Products, L.P.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Contrast Induced Nephropathy

Keywords

Contrast, Nephropathy, acute renal failure, Erythropoietin, CT scan

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erythropoeitin

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

erythropoeitin

Other Intervention Name(s)

PROCRIT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Comparison of incidence of rise in serum creatinine of 25% or more in the study group vs. placebo

Time Frame

7 days

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ajay K Singh, M.D.

Organizational Affiliation

Brigham and Womens Hospital and Harvard Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Womens hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial

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