NCT01364402

Brief Summary

This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI. The investigators assume that the incidence rate of CIN will be significantly lower in the EPO group compared to placebo. In addition, EPO administration will result in a decrease of infarct size.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 10, 2012

Status Verified

September 1, 2011

Enrollment Period

2 years

First QC Date

May 24, 2011

Last Update Submit

October 9, 2012

Conditions

DiabetesChronic Kidney Insufficiency

Keywords

scheduled for PCI

Outcome Measures

Primary Outcomes (1)

  • Incidence of Contrast Induced Nephropathy(CIN)

    1-3 days after exposure to contrast media

Secondary Outcomes (4)

  • Enzymatic infarct size

    6h and 12 h after exposure to contrast media

  • Hospital length of stay

    participants will be followed for the duration of hospital stay, an expected average of 3 days

  • Renal replacement therapy

    participants will be followed after PCI procedure till discharge, an expected average of 1-2 days

  • Hospital mortality

    participants will be followed after PCI procedure till discharge, an expected average of 1-2 days

Study Arms (2)

Erythropoietin

EXPERIMENTAL
Drug: Epoetin beta

Placebo

PLACEBO COMPARATOR
Drug: Saline 0.9%

Interventions

Epoetin betaDRUG

50,000U intravenously

Also known as: Epoietin beta
Erythropoietin
Saline 0.9%DRUG

normal saline intravenously

Also known as: Hydration
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age.
  • Diabetic patients.
  • eGFR \< 60 ml/min/1.73m2.
  • Scheduled for primary or elective PCI.

You may not qualify if:

  • Non diabetic patients.
  • Patients with eGFR ≥ 60 ml/min/1.73m2.
  • Chronic renal replacement therapy.
  • Subject with active malignancy.
  • Subject with any known history of seizure disorders.
  • Subject with polycythemia.
  • Uncontrolled hypertension.
  • Known allergy or hypersensitivity to EPO.
  • Use of EPO 1 week prior to randomization.
  • Use of long acting EPO (CERA) during 1 month prior to randomization.
  • Use of NAC or bicarbonate during 3 days prior to randomization.
  • Contrast media exposure during the last 7 days before randomization.
  • Pregnant or lactating women.
  • Participation in other clinical trial.
  • Refusal or inability to give informed consent due to mental or physical state.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Galilee Hospital

Nahariya, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39301879DERIVED

MeSH Terms

Conditions

Diabetes MellitusRenal Insufficiency, Chronic

Interventions

epoetin betaSodium Chloride

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Shaul Atar, MD

    Western Galilee Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilach Shema-Didi, RN, MPH

CONTACT

972-507887538lilach_01@yahoo.com

Lilach Shema-Didi, RN, MPH

CONTACT

Lilach.Shema-Didi@naharia.health.gov.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 24, 2011

First Posted

June 2, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

October 10, 2012

Record last verified: 2011-09

Locations

IL(1)