| CTRI Number |
CTRI/2009/091/000747 [Registered on: 24/09/2009] |
| Last Modified On: |
19/12/2012 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Post-Marketing Safety Study in Patients with Moderate Renal Insufficiency who receive Omniscan for Contrast-Enhanced Magnetic Resonance Imaging (MRI) |
Scientific Title of Study
Modification(s)
|
A Post-Marketing Safety Study in patients with Moderate Renal Insufficiency who receive Omniscan (gadodiamide
injection) for Contrast-Enhanced Magnetic Resonance
Imaging (MRI) of Protocol no.: GE-041-075 |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| GE-041-075 |
DCGI |
| NCT00908310 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. S. Kishore Babu, MD, DNB (Nephro) |
| Designation |
|
| Affiliation |
|
| Address |
Consultant Nephrologist, Manipal Hospital,#98,
Rustom Bagh, Airport Road,
Bangalore
KARNATAKA
560017
India |
| Phone |
09845043274 |
| Fax |
080 25207181 |
| Email |
drkishorebabu@vsnl.net |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jayesh Jani |
| Designation |
|
| Affiliation |
|
| Address |
GE Healthcare Pvt. Ltd.
Building No. 7A, 5th Floor, DLF Cyber City, Phase III
Gurgaon
HARYANA
122002
India |
| Phone |
09999039312 |
| Fax |
0124 4226915 |
| Email |
jayesh.jani@ge.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunil Dutt Pemmaraju |
| Designation |
|
| Affiliation |
|
| Address |
GE Healthcare Pvt Ltd., A1 Tower, 1st Floor, Golden Enclave
Airport Road
Bangalore
KARNATAKA
560017
India |
| Phone |
080 4018 3839 |
| Fax |
080 2520 2429 |
| Email |
sunil.dutt@ge.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
GE Healthcare Pvt Ltd., |
| Address |
|
| Type of Sponsor |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Varsha Joshi |
Apollo Hospitals |
MRI Section, Department of imaging,Jubilee Hills-500033
Hyderabad
ANDHRA PRADESH |
09849357397
040-23543270
dr_varshamj@rediffmail.com |
| Dr. A. L. Peria Karuppan |
Apollo Speciality Hospitals |
Department of Radiology,Lake View Road, K. K Nagar-625020
Madurai
TAMIL NADU |
09600009045
04522581157
smallarun@yahoo.com |
| Dr.S.Kishore Babu MD DNB (Nephro) |
Manipal Hospital, #98, Rustom Bagh, Airport Road, Bangalore-560017 |
,-560017
Bangalore
KARNATAKA |
98450 43274
drkishorebabu@vsnl.net |
| Dr. C. Kesavadas |
Sree Chitra Tirunal Institute for Medical Sciences & Technology |
,-695011
Thiruvananthapuram
KERALA |
09447047002
04712446433
kesav@sctimst.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospital and Manipal Heart Foundation, Manipal Hospital, Bangalore |
Approved |
| Ethics Committee, Apollo Hospitals, Jubilee Hills, Hyderabad 500033 |
Approved |
| Ethics Committee, Apollo Speciality Hospitals, Lake View Road, K. K. Nagar, Madurai, 625020 |
Approved |
| Institutional Ethics Committee,Sree Chitra Tirunal Institute For Medical Sciences & Technology, Thiruvanantapuram, 695011 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Kidney Disease
Renal Insufficiency
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Omniscan |
|
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent.
The subject is > 18 years of age at time of study entry.
The subject has known or suspected chronic kidney disease with an eGFR greater than or equal to 30mL and <60 mL/min/1.73 m2 as measured within 30 days prior to the planned index OMNISCAN administration(GFR will be
estimated all subjects using the MDRD GFR extended version calculator).
The subject agrees to be contacted for follow-up for 24 months.
|
|
| ExclusionCriteria |
| Details |
Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows:
1. skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching;
2. eyes - yellow raised spots on whites of eyes; or
3. bones and muscle - stiffness in joints; difficulty in moving or straightening of arms, hands, legs or feet; bone pain especially in hips and ribs or muscle weakness.
Patients allergic to any GBCA.
Patients with chronic renal disease with a GFR <30 mL/min/1.73 m2 as measured within 30 days prior to the planned OMNISCAN administration.
Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period.
Patients that were exposed to any GBCA within a period of 12 months prior the planned index administration of Omniscan. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To capture post-marketing safety information in patients with moderate renal insufficiency undergoing routine contrast-enhanced MRI with administration of OMNISCAN in order to assess the risk for developing nephrogenic systemic fibrosis. [ Time Frame: Time zero equals the date of Omniscan injection. All subjects will be followed for approximately 2 years after the administration of Omniscan ] [ Designated as safety issue: Yes ]
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Development of NSF in 2 years follow up period confirmed histologically |
All subjects will be followed for approximately 2 years after the Omniscan administration. Time zero equals the date of Omniscan injection.
|
|
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Target Sample Size
|
Total Sample Size="600"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/01/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This will be a Global study which is conducted in upto 100 centres worldwide. The study is designed to collect safety data that assesses the occurrence of NSF among patients with moderate renal insufficiency who are administered Omniscan (gadodiamide) injection, during a MRI with a 2 year follow-up period.
Target enrollment is approximately 600 patients globally. The patient recruitment started 10 June 2009 and is expected to be completed by late 2010.
Omniscan will be administered intravenously in 100 patients in India as per the approval from DCGI, at the medical discretion of the prescribing physician. Date of enrollment for Indian patient will be somewhere in 30 January 2010. |