search
Back to results

Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction (RIPE)

Primary Purpose

Kidney Failure, Chronic

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
iodixanol
iopromide
Sponsored by
Yong Huo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure, Chronic focused on measuring Chronic Kidney Disease, Coronary Angiography, Contrast Media, Percutaneous Coronary Intervention, Serum Creatinine, Glomerular Filtration Rate, Iodixanol, Iopromide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provides written Informed Consent and is willing to comply with protocol requirements
  • Is referred for cardiac angiography, with or without PCI
  • Has a documented predose serum creatinine level of 1.5～3.5 mg/dl for men and 1.3～3.0 mg/dl for women
  • Serum creatinine levels of twice tests conform with the baseline criteria, and the difference of twice serum creatinine tests is not more than 30%(first test: within 3 month,prior to enrollment; second test: at enrollment)

Exclusion Criteria:

  • Has a history of hypersensitivity to iodine-containing compounds
  • Has end-stage renal disease
  • Has kidney transplantation
  • Has creatinine clearance rates >60 ml/min in last 3 months
  • Has acute coronary syndrome with heart failure(above class II in accordance with Killip or class III in accordance with the classification of the New York Heart Association (NYHA)) and shock
  • Patients with cancer
  • Has diabetes with serious complications, other kidney organs
  • Patients with serious blood system disease
  • Heart failure [class III~Ⅳ in accordance with the classification of the New York Heart Association (NYHA) and (or) pulmonary edema]
  • Patients with hepatic insufficiency[3 times as ALT and (or) AST normal reference value limit]
  • Has received an iodinated contrast agent within 14 days prior to the administration of the study agent
  • Is scheduled to receive an iodinated contrast agent within 7 days after administration of the study agent
  • Has acute renal failure or end-stage renal disease requiring dialysis in the past 3 months
  • Use of 3 days continuously nonsteroidal anti-inflammatory drugs within 1 week of the procedure
  • Patients with hypotension [(SBP<80 mmHg for over 1h and needing Medication or intraaortic balloon counterpulsation(IABP) ]
  • Uncontrolled condition of hyperthyroidism
  • pregnancy or lactation
  • Is planned to receive the drugs without permission in this protocol
  • Participating in another intervention research study in last 3 months
  • legally incapacitated or limitations
  • Any other conditions not suitable to be enrollment

Sites / Locations

  • Anhui Provincial HospitalRecruiting
  • Peking University First HospitalRecruiting
  • Fujian Medical University Union Hospital
  • Guangdong Academy Of Medical Sciences Guangdong General Hospital
  • The First Affiliated Hospital Of Guangxi Medical UniversityRecruiting
  • The People's Hospital Of Hebei Province
  • Henan Provincial People's Hospital
  • The Second Affiliated Hospital To Nanchang University
  • The People's Hospital Of Liaoning ProvinceRecruiting
  • The Affiliated Hospital Of Medical College Qingdao University
  • Shanxi Cardiovascular Hospital
  • Peking University People's Hospital
  • Pla Navy General HospitalRecruiting
  • The Central Hospital Of China Aerospace CorporationRecruiting
  • Chinese PLA General Hospital
  • Xinqiao Hospital, Third Military Medical University
  • Renji Hospital ，Shanghai Jiao Tong University School Of Medicine
  • Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University
  • Shanghai First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iodixanol

iopromide

Arm Description

Outcomes

Primary Outcome Measures

to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate

Secondary Outcome Measures

In each group(Iodixanol group and Iopromide group), the proportion of patients exhibiting an increases of serum creatinine in different range(<10%,10%~25%, and ≥25%), comparing with baseline level.
Incidence of hemodialysis
Changes of Cystatin C level from baseline

Full Information

First Posted
April 16, 2012
Last Updated
October 14, 2013
Sponsor
Yong Huo
search

1. Study Identification

Unique Protocol Identification Number
NCT01580046
Brief Title
Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction
Acronym
RIPE
Official Title
Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction-a Multicentre, Single Blind, Randomized Controlled, Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong Huo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.
Detailed Description
The study is designed to compare renal toxicity of Iodixanol and Iopromide after coronary angiography or percutaneous coronary intervention (PCI) in patient with Chronic Kidney Disease, considering original renal function and adequate hydration. The risk of varying degree of renal impairment, changes of serum Cys C level will also be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Chronic Kidney Disease, Coronary Angiography, Contrast Media, Percutaneous Coronary Intervention, Serum Creatinine, Glomerular Filtration Rate, Iodixanol, Iopromide

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iodixanol
Arm Type
Experimental
Arm Title
iopromide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
iodixanol
Intervention Description
coronary angiography, 32gI/100ml, 40～60 ml once injection left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30～60 ml once injection
Intervention Type
Drug
Intervention Name(s)
iopromide
Other Intervention Name(s)
Ultravist
Intervention Description
coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection
Primary Outcome Measure Information:
Title
to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate
Time Frame
days 3 and 7
Secondary Outcome Measure Information:
Title
In each group(Iodixanol group and Iopromide group), the proportion of patients exhibiting an increases of serum creatinine in different range(<10%,10%~25%, and ≥25%), comparing with baseline level.
Time Frame
days 3 and 7
Title
Incidence of hemodialysis
Time Frame
days 3 and 7
Title
Changes of Cystatin C level from baseline
Time Frame
days 1 and 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provides written Informed Consent and is willing to comply with protocol requirements Is referred for cardiac angiography, with or without PCI Has a documented predose serum creatinine level of 1.5～3.5 mg/dl for men and 1.3～3.0 mg/dl for women Serum creatinine levels of twice tests conform with the baseline criteria, and the difference of twice serum creatinine tests is not more than 30%(first test: within 3 month,prior to enrollment; second test: at enrollment) Exclusion Criteria: Has a history of hypersensitivity to iodine-containing compounds Has end-stage renal disease Has kidney transplantation Has creatinine clearance rates >60 ml/min in last 3 months Has acute coronary syndrome with heart failure(above class II in accordance with Killip or class III in accordance with the classification of the New York Heart Association (NYHA)) and shock Patients with cancer Has diabetes with serious complications, other kidney organs Patients with serious blood system disease Heart failure [class III~Ⅳ in accordance with the classification of the New York Heart Association (NYHA) and (or) pulmonary edema] Patients with hepatic insufficiency[3 times as ALT and (or) AST normal reference value limit] Has received an iodinated contrast agent within 14 days prior to the administration of the study agent Is scheduled to receive an iodinated contrast agent within 7 days after administration of the study agent Has acute renal failure or end-stage renal disease requiring dialysis in the past 3 months Use of 3 days continuously nonsteroidal anti-inflammatory drugs within 1 week of the procedure Patients with hypotension [(SBP<80 mmHg for over 1h and needing Medication or intraaortic balloon counterpulsation(IABP) ] Uncontrolled condition of hyperthyroidism pregnancy or lactation Is planned to receive the drugs without permission in this protocol Participating in another intervention research study in last 3 months legally incapacitated or limitations Any other conditions not suitable to be enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaoping Liu, MD
Phone
86-10-83575727
Email
dr_liuzhp@yahoo.com.cn
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Yan, MD
First Name & Middle Initial & Last Name & Degree
Kefu Feng, MD
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Huo, MD
First Name & Middle Initial & Last Name & Degree
Zhaoping Liu, MD
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianglong Chen, MD
First Name & Middle Initial & Last Name & Degree
Xingchun Zheng, MD
Facility Name
Guangdong Academy Of Medical Sciences Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiyan Chen, MD
First Name & Middle Initial & Last Name & Degree
Yong Liu, MD
Facility Name
The First Affiliated Hospital Of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lang Li, MD
First Name & Middle Initial & Last Name & Degree
Xiaocong Zeng, MD
Facility Name
The People's Hospital Of Hebei Province
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyong Qi, MD
First Name & Middle Initial & Last Name & Degree
Tianhong Wang, MD
Facility Name
Henan Provincial People's Hospital
City
Luoyang
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanyu Gao, MD
Facility Name
The Second Affiliated Hospital To Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoshu Cheng, MD
First Name & Middle Initial & Last Name & Degree
Yanqing Wu, MD
Facility Name
The People's Hospital Of Liaoning Province
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanquan Li, MD
First Name & Middle Initial & Last Name & Degree
Yongxin Wang, MD
Facility Name
The Affiliated Hospital Of Medical College Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi An, MD
First Name & Middle Initial & Last Name & Degree
Hua Yu, MD
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030024
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bao Li, MD
First Name & Middle Initial & Last Name & Degree
Zhongchao Wang, MD
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Wang, MD
Facility Name
Pla Navy General Hospital
City
Beijing
ZIP/Postal Code
100048
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianchang Li, MD
Facility Name
The Central Hospital Of China Aerospace Corporation
City
Beijing
ZIP/Postal Code
100049
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Wang, MD
First Name & Middle Initial & Last Name & Degree
Tao Qu, MD
First Name & Middle Initial & Last Name & Degree
Ying Shen, MD
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yundai Chen, MD
First Name & Middle Initial & Last Name & Degree
Wei Dong, MD
First Name & Middle Initial & Last Name & Degree
Sunying Hu, MD
Facility Name
Xinqiao Hospital, Third Military Medical University
City
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Huang, MD
First Name & Middle Initial & Last Name & Degree
Jun Jin, MD
First Name & Middle Initial & Last Name & Degree
Yun He, MD
Facility Name
Renji Hospital ，Shanghai Jiao Tong University School Of Medicine
City
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben He, MD
Facility Name
Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiyi Fang, MD
Facility Name
Shanghai First People's Hospital
City
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaowen Liu, MD

12. IPD Sharing Statement

Learn more about this trial

Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction

We'll reach out to this number within 24 hrs