Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction

Kidney Failure, Chronic Clinical Trial

— RIPE  

Official title:

Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction—a Multicentre, Single Blind, Randomized Controlled, Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01580046
• Other study ID #: XNK201201
• Status: Recruiting
• Phase: Phase 4
• First received: April 16, 2012
• Last updated: October 14, 2013
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2013
• Source: Peking University First Hospital
• Contact: Zhaoping Liu, MD
• Phone: 86-10-83575727
• Email: dr_liuzhp[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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~? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• iodixanol
coronary angiography, 32gI/100ml, 40~60 ml once injection left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30~60 ml once injection
• iopromide
coronary angiography, 370mgI/ml(0.769gIopromide/ml),5~8 ml once injection

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing
China	Pla Navy General Hospital	Beijing
China	The Central Hospital Of China Aerospace Corporation	Beijing
China	Xinqiao Hospital, Third Military Medical University	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Guangdong Academy Of Medical Sciences Guangdong General Hospital	Guangzhou	Guangdong
China	Anhui Provincial Hospital	Hefei	Anhui
China	Henan Provincial People's Hospital	Luoyang	Henan
China	The Second Affiliated Hospital To Nanchang University	Nanchang	Jiangxi
China	The First Affiliated Hospital Of Guangxi Medical University	Nanning	Guangxi
China	The Affiliated Hospital Of Medical College Qingdao University	Qingdao	Shandong
China	Renji Hospital ,Shanghai Jiao Tong University School Of Medicine	Shanghai
China	Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University	Shanghai
China	Shanghai First People's Hospital	Shanghai
China	The People's Hospital Of Liaoning Province	Shenyang	Liaoning
China	The People's Hospital Of Hebei Province	Shijiazhuang	Hebei
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Yong Huo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate		days 3 and 7	No
Secondary	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.		days 3 and 7	No
Secondary	Incidence of hemodialysis		days 3 and 7	Yes
Secondary	Changes of Cystatin C level from baseline		days 1 and 3	No