Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial

Contrast Induced Nephropathy Clinical Trial

— ERIN  

Official title:

Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00476619
• Other study ID #: 2004P000510
• Status: Terminated
• Phase: Phase 4
• First received: May 21, 2007
• Last updated: April 2, 2009
• Start date: September 2004
• Est. completion date: June 2008

Study information

• Verified date: April 2009
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: June 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Womens hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Ortho Biotech Products, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of incidence of rise in serum creatinine of 25% or more in the study group vs. placebo		7 days	Yes
Secondary	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		7 days	Yes