Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction (RIPE)
This study is not yet open for participant recruitment.
Verified April 2012 by Peking University First Hospital
Sponsor:
Yong Huo
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01580046
First received: April 16, 2012
Last updated: April 17, 2012
Last verified: April 2012
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Purpose
The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Failure, Chronic |
Drug: iodixanol Drug: iopromide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction—a Multicentre, Single Blind, Randomized Controlled, Prospective Trial |
Resource links provided by NLM:
Further study details as provided by Peking University First Hospital:
Primary Outcome Measures:
- to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate [ Time Frame: days 3 and 7 ] [ Designated as safety issue: No ]
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. [ Time Frame: days 3 and 7 ] [ Designated as safety issue: No ]
- Incidence of hemodialysis [ Time Frame: days 3 and 7 ] [ Designated as safety issue: Yes ]
- Changes of Cystatin C level from baseline [ Time Frame: days 1 and 3 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Iodixanol |
Drug: iodixanol
|
| Active Comparator: iopromide |
Drug: iopromide
coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection
Other Name: Ultravist
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580046
Contacts
| Contact: Zhaoping Liu, MD | 86-10-83575727 | dr_liuzhp@yahoo.com.cn |
Locations
| China, Anhui | |
| Anhui Provincial Hospital | Not yet recruiting |
| Hefei, Anhui, China, 230001 | |
| Principal Investigator: Ji Yan, MD | |
| Sub-Investigator: Kefu Feng, 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 | Not yet 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 | Not yet 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 | |
| China, Zhejiang | |
| Second Affiliated Hospital Zhejiang University College Of Medcine | Not yet recruiting |
| Hangzhou, Zhejiang, China, 310009 | |
| Principal Investigator: Jianan Wang, MD | |
| China | |
| Pla Navy General Hospital | Not yet recruiting |
| Beijing, China, 100048 | |
| Principal Investigator: Tianchang Li, MD | |
| The Central Hospital Of China Aerospace Corporation | Not yet 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 | |
| Peking University People's Hospital | Not yet recruiting |
| Beijing, China, 100044 | |
| Principal Investigator: Weimin Wang, 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 | |
| Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University | Not yet recruiting |
| Shanghai, China, 200030 | |
| Principal Investigator: Weiyi Fang, MD | |
| Renji Hospital ，Shanghai Jiao Tong University School Of Medicine | Not yet recruiting |
| Shanghai, China, 200001 | |
| Principal Investigator: Ben He, MD | |
| Shanghai First People's Hospital | Not yet recruiting |
| Shanghai, China, 200080 | |
| Principal Investigator: Shaowen Liu, MD | |
Sponsors and Collaborators
Yong Huo
More Information
No publications provided
| Responsible Party: | Yong Huo, MD, Peking University First Hospital |
| ClinicalTrials.gov Identifier: | NCT01580046 History of Changes |
| Other Study ID Numbers: | XNK201201 |
| Study First Received: | April 16, 2012 |
| Last Updated: | April 17, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Peking University First Hospital:
|
Chronic Kidney Disease Coronary Angiography Contrast Media Percutaneous Coronary Intervention |
Serum Creatinine Glomerular Filtration Rate Iodixanol Iopromide |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013