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Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial

This study has been terminated.
(The exclusion criteria were stringent and enrollment was slow.)
Sponsor:
Collaborator:
Ortho Biotech Products, L.P.
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00476619
First received: May 21, 2007
Last updated: April 2, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Contrast Induced Nephropathy
 Drug: erythropoeitin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Comparison of incidence of rise in serum creatinine of 25% or more in the study group vs. placebo [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: September 2004
Study Completion Date: June 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: 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.
Other Name: PROCRIT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476619

Locations
United States, Massachusetts
Brigham and Womens hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Ortho Biotech Products, L.P.
Investigators
Principal Investigator: Ajay K Singh, M.D. Brigham and Womens Hospital and Harvard Medical School
  More Information

No publications provided

Responsible Party: Dr Ajay K Singh, MD MBA FRCP, Brigham and Womens Hospital
ClinicalTrials.gov Identifier: NCT00476619     History of Changes
Other Study ID Numbers: 2004P000510
Study First Received: May 21, 2007
Last Updated: April 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Contrast
Nephropathy
acute renal failure
Erythropoietin
CT scan

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013