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Kidney Failure, ChronicPhase 4RIPENCT01580046

Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction

A Phase 4 study testing iodixanol and iopromide in people with Kidney Failure, Chronic, run by Yong Huo at 19 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Kidney Failure, Chronic
What is being tested?
iodixanol and iopromide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
19 sitesChina
Study dates
Apr 2012to Dec 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

19 sites in 1 country.

Zhaoping Liu, MD contact

86-10-83575727

dr_liuzhp@yahoo.com.cn

19 sites in 1 country

China19 sites, 19 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100044

    Yong Huo, MD

    Zhaoping Liu, MD

    Recruiting

  • Peking University People's Hospital

    Beijing, 100044

    Weimin Wang, MD

    Not yet recruiting

  • Pla Navy General Hospital

    Beijing, 100048

    Tianchang Li, MD

    Recruiting

  • The Central Hospital Of China Aerospace Corporation

    Beijing, 100049

    Bin Wang, MD

    Tao Qu, MD

    Recruiting

  • Chinese PLA General Hospital

    Beijing, 100853

    Yundai Chen, MD

    Wei Dong, MD

    Not yet recruiting

  • Xinqiao Hospital, Third Military Medical University

    Chongqing, 400037

    Lan Huang, MD

    Jun Jin, MD

    Not yet recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Lianglong Chen, MD

    Xingchun Zheng, MD

    Not yet recruiting

  • Guangdong Academy Of Medical Sciences Guangdong General Hospital

    Guangzhou, Guangdong, 510080

    Jiyan Chen, MD

    Yong Liu, MD

    Not yet recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

    Ji Yan, MD

    Kefu Feng, MD

    Recruiting

  • Henan Provincial People's Hospital

    Luoyang, Henan, 450000

    Chuanyu Gao, MD

    Not yet recruiting

  • The Second Affiliated Hospital To Nanchang University

    Nanchang, Jiangxi, 330006

    Xiaoshu Cheng, MD

    Yanqing Wu, MD

    Not yet recruiting

  • The First Affiliated Hospital Of Guangxi Medical University

    Nanning, Guangxi, 530021

    Lang Li, MD

    Xiaocong Zeng, MD

    Recruiting

  • The Affiliated Hospital Of Medical College Qingdao University

    Qingdao, Shandong, 266003

    Yi An, MD

    Hua Yu, MD

    Not yet recruiting

  • Renji Hospital ，Shanghai Jiao Tong University School Of Medicine

    Shanghai, 200001

    Ben He, MD

    Not yet recruiting

  • Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University

    Shanghai, 200030

    Weiyi Fang, MD

    Not yet recruiting

  • Shanghai First People's Hospital

    Shanghai, 200080

    Shaowen Liu, MD

    Not yet recruiting

  • The People's Hospital Of Liaoning Province

    Shenyang, Liaoning, 110016

    Zhanquan Li, MD

    Yongxin Wang, MD

    Recruiting

  • The People's Hospital Of Hebei Province

    Shijiazhuang, Hebei, 050051

    Xiaoyong Qi, MD

    Tianhong Wang, MD

    Not yet recruiting

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, 030024

    Bao Li, MD

    Zhongchao Wang, MD

    Not yet recruiting

Other trials in China

About this study

Official title: Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction-a Multicentre, Single Blind, Randomized Controlled, Prospective Trial

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

Read the 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.

Being tested
iodixanol, iopromide
Keywords
Chronic Kidney Disease, Coronary Angiography, Contrast Media, Percutaneous Coronary Intervention, Serum Creatinine, Glomerular Filtration Rate, Iodixanol, Iopromide
Medical subject headings
Kidney Failure, Chronic, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iodixanolDrug

    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

  • iopromideDrug

    Also called Ultravist

    coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection

Study groups in NCT01580046
Study groupRoleWhat they receive
IodixanolExperimentalNot described
Receives: Drug: iodixanol
iopromideActive comparatorNot described
Receives: Drug: iopromide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: days 3 and 7

Secondary outcomes (3)

  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.

    Measured: days 3 and 7

  2. Incidence of hemodialysis

    Measured: days 3 and 7

  3. Changes of Cystatin C level from baseline

    Measured: days 1 and 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionDec 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01580046
Sponsor's protocol ID
XNK201201
Acronym
RIPE
Status last verified
Oct 2013
First submitted
16 Apr 2012
Last updated
16 Oct 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing iodixanol and iopromide in people with Kidney Failure, Chronic, run by Yong Huo at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhaoping Liu, MD (86-10-83575727, dr_liuzhp@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate (time frame: days 3 and 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01580046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.

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