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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01580046
Recruitment Status : Unknown
Verified October 2013 by Yong Huo, Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : April 18, 2012
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital

Brief Summary:
The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: iodixanol Drug: iopromide Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction—a Multicentre, Single Blind, Randomized Controlled, Prospective Trial
Study Start Date : April 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Iodixanol Drug: iodixanol
  1. coronary angiography, 32gI/100ml, 40~60 ml once injection
  2. left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30~60 ml once injection

Active Comparator: iopromide Drug: iopromide
coronary angiography, 370mgI/ml(0.769gIopromide/ml),5~8 ml once injection
Other Name: Ultravist

Primary Outcome Measures :
  1. to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate [ Time Frame: days 3 and 7 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Incidence of hemodialysis [ Time Frame: days 3 and 7 ]
  3. Changes of Cystatin C level from baseline [ Time Frame: days 1 and 3 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01580046

Contact: Zhaoping Liu, MD 86-10-83575727

China, Anhui
Anhui Provincial Hospital Recruiting
Hefei, Anhui, China, 230001
Principal Investigator: Ji Yan, MD         
Sub-Investigator: Kefu Feng, MD         
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100044
Principal Investigator: Yong Huo, MD         
Sub-Investigator: Zhaoping Liu, MD         
China, Fujian
Fujian Medical University Union Hospital Not yet recruiting
Fuzhou, Fujian, China, 350001
Principal Investigator: Lianglong Chen, MD         
Sub-Investigator: Xingchun Zheng, MD         
China, Guangdong
Guangdong Academy Of Medical Sciences Guangdong General Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510080
Principal Investigator: Jiyan Chen, MD         
Sub-Investigator: Yong Liu, MD         
China, Guangxi
The First Affiliated Hospital Of Guangxi Medical University Recruiting
Nanning, Guangxi, China, 530021
Principal Investigator: Lang Li, MD         
Sub-Investigator: Xiaocong Zeng, MD         
China, Hebei
The People's Hospital Of Hebei Province Not yet recruiting
Shijiazhuang, Hebei, China, 050051
Principal Investigator: Xiaoyong Qi, MD         
Sub-Investigator: Tianhong Wang, MD         
China, Henan
Henan Provincial People's Hospital Not yet recruiting
Luoyang, Henan, China, 450000
Principal Investigator: Chuanyu Gao, MD         
China, Jiangxi
The Second Affiliated Hospital To Nanchang University Not yet recruiting
Nanchang, Jiangxi, China, 330006
Principal Investigator: Xiaoshu Cheng, MD         
Sub-Investigator: Yanqing Wu, MD         
China, Liaoning
The People's Hospital Of Liaoning Province Recruiting
Shenyang, Liaoning, China, 110016
Principal Investigator: Zhanquan Li, MD         
Sub-Investigator: Yongxin Wang, MD         
China, Shandong
The Affiliated Hospital Of Medical College Qingdao University Not yet recruiting
Qingdao, Shandong, China, 266003
Principal Investigator: Yi An, MD         
Sub-Investigator: Hua Yu, MD         
China, Shanxi
Shanxi Cardiovascular Hospital Not yet recruiting
Taiyuan, Shanxi, China, 030024
Principal Investigator: Bao Li, MD         
Sub-Investigator: Zhongchao Wang, MD         
Peking University People's Hospital Not yet recruiting
Beijing, China, 100044
Principal Investigator: Weimin Wang, MD         
Pla Navy General Hospital Recruiting
Beijing, China, 100048
Principal Investigator: Tianchang Li, MD         
The Central Hospital Of China Aerospace Corporation Recruiting
Beijing, China, 100049
Principal Investigator: Bin Wang, MD         
Sub-Investigator: Tao Qu, MD         
Sub-Investigator: Ying Shen, MD         
Chinese PLA General Hospital Not yet recruiting
Beijing, China, 100853
Principal Investigator: Yundai Chen, MD         
Sub-Investigator: Wei Dong, MD         
Sub-Investigator: Sunying Hu, MD         
Xinqiao Hospital, Third Military Medical University Not yet recruiting
Chongqing, China, 400037
Principal Investigator: Lan Huang, MD         
Sub-Investigator: Jun Jin, MD         
Sub-Investigator: Yun He, MD         
Renji Hospital ,Shanghai Jiao Tong University School Of Medicine Not yet recruiting
Shanghai, China, 200001
Principal Investigator: Ben He, MD         
Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University Not yet recruiting
Shanghai, China, 200030
Principal Investigator: Weiyi Fang, MD         
Shanghai First People's Hospital Not yet recruiting
Shanghai, China, 200080
Principal Investigator: Shaowen Liu, MD         
Sponsors and Collaborators
Yong Huo

Responsible Party: Yong Huo, MD, Peking University First Hospital Identifier: NCT01580046     History of Changes
Other Study ID Numbers: XNK201201
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by Yong Huo, Peking University First Hospital:
Chronic Kidney Disease
Coronary Angiography
Contrast Media
Percutaneous Coronary Intervention
Serum Creatinine
Glomerular Filtration Rate

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic