Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial

NCT ID: NCT00476619

Last Updated: 2009-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2008-06-30

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.

Conditions

Contrast Induced Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

erythropoeitin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

PROCRIT

Eligibility Criteria

Inclusion Criteria

1. Subjects age 18 and over and of either gender.

2. Scheduled to receive CT scan with intravenous contrast dye.

3. Non diabetics or subjects with type 1 or 2 diabetes mellitus

4. Written informed consent.

5. Subjects who are on diuretics and non-steroidal inflammatory agents will not be excluded.

6. Subjects who have received n-acetylcysteine or sodium bicarbonate pre CT scan will not be excluded

Exclusion Criteria

1. Pregnant or lactating women.

2. End-stage renal disease (on hemodialysis or peritoneal dialysis)

3. A known history of acute renal failure

4. Subjects receiving glucophage/metformin or glucovance

5. Subjects who cannot give written informed consent.

6. Subjects receiving peritoneal dialysis or hemodialysis.

7. Subjects enrolled in another investigational drug study ≤ 30 days of enrollment into the present study.

8. Subjects with a known hypersensitivity or anaphylaxis to contrast dye or iodine.

9. Subjects with known hypersensitivity or anaphylaxis to erythropoietin, mammalian-cell derived products, or human albumin.

10. Age < 18 years

11. Use of any erythropoietin replacement or transfusion within the prior 3 days

12. Baseline Hemoglobin > 12.0 g/dL

13. Uncontrolled hypertension, systolic BP > 180 mmHg or diastolic BP > 110 mmHg in any recording in the past 24 hours.

14. Evidence of hemodynamic instability

15. Subject unable to follow protocol due to mental incompetence or other reason

16. Inaccessibility of medical record

17. Subjects with a history of MI, CVA, active angina or unstable angina within the past three months

18. 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.

19. Subject with any known history of seizure disorders

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech Products, L.P.

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brigham and Womens Hospital

Principal Investigators

Ajay K Singh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Womens Hospital and Harvard Medical School

Locations

Brigham and Womens hospital

Boston, Massachusetts, United States

Countries

United States

References

Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.

Reference Type: DERIVED

PMID: 39301879 (View on PubMed)

Other Identifiers

2004P000510

Identifier Type: -

Identifier Source: org_study_id