| CTRI Number |
CTRI/2014/06/004672 [Registered on: 13/06/2014] Trial Registered Prospectively |
| Last Modified On: |
29/09/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study is aimed at assessing the safety of SmofKabiven® (to be registered in India) in comparison to Kabiven (already marketed in India) in patients with gastrointestinal disorders requiring parenteral nutrition |
|
Scientific Title of Study
|
Safety and Tolerance of SmofKabiven@versus Kabiven@:An
Open, Randomized, Controlled, Multi-Centre, Non-Inferiority Study in Adult
Patients Requiring Parenteral Nutrition after Major Abdominal Surgery
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SMKV-008-CP3 Version 1.1 dated 24 Jul 2013 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Jayashri Krishnan |
| Designation |
Deputy Head-Operations |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
No 13, 45th Street, Nanganallur,
Chennai
TAMIL NADU
600061
India |
| Phone |
91-4443102501 |
| Fax |
91-4443588940 |
| Email |
jayashri.krishnan@jssresearch.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sonika Newar |
| Designation |
Medical Monitor |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D
Faridabad
HARYANA
121003
India |
| Phone |
91-129-6613500 |
| Fax |
91-129-6613520 |
| Email |
sonika.newar@jssresearch.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shariq Anwar |
| Designation |
Head Operations |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D
Faridabad
HARYANA
121003
India |
| Phone |
91-129-6613500 |
| Fax |
91-129-6613520 |
| Email |
shariq.anwar@jssresearch.com |
|
|
Source of Monetary or Material Support
|
| Fresenius Kabi Deutschland GmbH (Parent Company), Else-Kroener-Str. 1, 61352 Bad Homburg, Germany |
|
Primary Sponsor
Modification(s)
|
| Name |
Fresenius Kabi India Pvt Ltd |
| Address |
Fifth Floor, A wing, Ashoka Plaza, Pune-Nagar Road, Survey No. 32/2, Vadgaon Sheri, Viman Nagar, Pune- 411014, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K V V N Raju |
Basavatarakam Indo American Cancer Hospital & Research Institute |
Department of surgical oncololgy,Road No 10, Banjara Hills, Telangana 500034
Hyderabad
ANDHRA PRADESH |
9848028645
drkvvnraju2002@yahoo.co.in |
| Dr Kona S Lakshmi Kumari |
Global Hospitals |
Department of Surgical Gastroenterology And Laproscopic Surgery, 6-1-1070/1 to 4, Lakdi-ka-pool, Telangana State- 500004
Hyderabad
ANDHRA PRADESH |
9849713853
lakshmi.kona@yahoo.com |
| Dr Nilesh Doctor |
Jaslok Hospital & Research Centre |
Department of Surgical Gastroenterology, 15, Dr. G. Deshmukh Marg, Mumbai 400026
Mumbai
MAHARASHTRA |
9821131646
drnileshbela@gmail.com |
| Dr Ramesh Ardhanari |
Meenakshi Mission Hospital & Research Centre |
Department of Surgery & Gastroenterology, Lake Area,
Melur Road, Madurai - 625107
Madurai
TAMIL NADU |
9842178789
drrameshardhanari@gmail.com |
| Dr BS Madhu |
Mysore Medical College and Research Institute |
Department of General Surgery,Irwin Road, Mysore
Karnataka - 570001
Mysore
KARNATAKA |
9900513688
drmadhubs@gmail.com |
| Dr Amitava Chakraborthy |
Peerless Hospitex Hospital and Research Center Limited |
Department of General Surgery, 360, Panchasayar, Kolkata – 700094, West Bengal, India.
Kolkata
WEST BENGAL |
9830036462
amitava.dr@gmail.com |
| Dr Amit Goyal |
Sawai Man Singh (SMS) Hospital |
Department of General Surgery, JLN Marg, Jaipur – 302004, Rajasthan
Jaipur
RAJASTHAN |
9413566614
drgoyalamit2010@gmail.com |
| Dr Rajeev M Joshi |
Topiwala National (T.N.) Medical College & B. Y. L. Nair Charitable Hospital |
Department of General Surgery, Dr. A. L. Nair Road, Mumbai Central,
Mumbai – 400008
Mumbai
MAHARASHTRA |
9820540565
rajeevjoshi50@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee Mysore Medical College and Research Institute and Associated Hospital |
Approved |
| Ethics Committee of Topiwala National Medical College and B.Y. L Nair Charitable Hospital |
Approved |
| Institutional Ethics Committee - Jaslok Hospital & Research Centre |
Approved |
| Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre |
Approved |
| Institutional Ethics Committee, Basavatarakam Indo American cancer hospital and Research Institute, Hyderabad, Telangana |
Approved |
| Institutional Ethics Committee, Global Hospitals, Hyderabad, Telangana |
Approved |
| Institutional Ethics Committee- Peerless Hospital and B.K. Roy Research Centre-Clinical Research Ethics Committee |
Approved |
| Office of the Ethics Committee SMS Medical College and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Adult patients requiring parenteral nutrition after major abdominal surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kabiven® emulsion for infusion |
Kabiven® emulsion for infusion (Fresenius Kabi AB, Uppsala, Sweden);
Active ingredients: essential, conditionally essential and non-essential amino acids, glucose, electrolytes and soybean oil.
• Control product will be administered via central venous infusion over 4-7 days at individualized daily doses. Target: provision of 23-27 k cal/kg body weight/day
|
| Intervention |
SmofKabiven® emulsion for infusion |
SmofKabiven® emulsion for infusion (Fresenius Kabi AB, Uppsala, Sweden); Active ingredients: essential, conditionally essential and non-essential amino acids, glucose, electrolytes, soybean oil, medium-chained triglycerides, olive oil, and fish oil.
• Test product will be administered via central venous infusion over 4-7 days at individualized daily doses. Target: provision of 23-27 k cal/kg body weight/day
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Female or male patients of any ethnicity
2. Patient is scheduled to undergo elective major abdominal surgery including surgery for cancer and non-cancer reasons including distant metastases with completely and incompletely resectable tumors: e.g., surgery for bleeding duodenal ulcer, gastrectomy, resection of small bowel, appendectomy, splenectomy, colectomy, vascular surgery, hysterectomy, ovarectomy
3. Patient has or is scheduled to peri-operatively receive a central venous catheter for routine medical care purposes
4. MELD score ≥7 and ≤29
5. Patient is expected to require PN for a minimum of 4 and maximum of 7 consecutive days
6. Patient is expected to receive ≥70 % of the individual energy demand by PN for a minimum of 4 days
7. Age between 18 and 65 years
8. BMI ≥16 and ≤35 kg/m2
9. Patient is capable to give Informed Consent
10. Informed Consent form signed by the patient or an impartial witness. |
|
| ExclusionCriteria |
| Details |
1. Elective surgeries possible interfering with the parameters important in calculating the primary outcome measure: excessive hepatectomy with less than 50% of viable tissue remaining, cholecystectomy, nephrectomy
2. Patient is expected to receive more than 30% of the individual energy demand by ON/EN during the first 4 days of treatment
3. Acute organ transplantations (liver, pancreas, small bowel, kidney)
4. Patient has received PN (lipids and/ or amino acids with glucose) in the last 10 days prior to screening (the sole administration of glucose will be allowed)
5. Known or expected hypersensitivity to fish-, egg-, soybean-, olive or peanut protein or to any of the active substances or excipients
6. Severe renal impairment (creatinine clearance [CLCR] <30 ml/min)
7. INR >2.5
8. Severe liver insufficiency or total bilirubin 3-times higher than the upper limit of normal
9. Inborn error of amino acid metabolism
10. Present signs of acute pancreatitis as diagnosed by clinical features
11. High likelihood of severe and life-threatening complications related to initial measures in the attempt to control the underlying disease
12. Instable septic shock or any other highly vulnerable condition of the cardiovascular system, such as uncompensated cardiac insufficiency/congestive heart failure
13. Severe metabolic acidosis
14. Hyperhydration or fluid overload and/or pulmonary oedema
15. Uncontrolled hyperglycaemia
16. Severe hyperlipidaemia
17. Pathologically elevated serum levels of any of the included electrolytes
18. Haemophagocytic syndrome
19. Any serious or clinically relevant condition that would preclude participation in the study (in the opinion of the investigator)
20. Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during study
21. Patient is pregnant or lactating and intends to continue breast-feeding |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary variable:
The primary safety parameter will be the relative reduction of the individual Model of End Stage Liver Disease (MELD) score at the final visit versus baseline (pre-surgery, screening visit).The MELD score is a composite score combining the officially acknowledged surrogate markers for hepatic and renal function (bilirubin, INR and creatinine, respectively).
• Outcome: safety
• Metric: Model of End Stage Liver Disease (MELD) score
|
Final visit versus pre-surgery screening visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Individual total number of adverse events (AEs)
Severity, seriousness, clinical relevance, relatedness and outcome of AEs
Various Laboratory variables e.g. CBC, Hb, Liver function test, Renal function test etc
Vital signs: blood pressure, heart rate, respiratory rate, body temperature
Number of days on PN for each of the study drugs
Amount of volume administered daily allowing to calculate delivered calories, fat, amino acids, and glucose
Secondary outcome: Lab parameter
|
Pre surgery versus final lab value |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/07/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, randomized, controlled, open, multicentre, non-inferiority clinical trial assessing the Safety and tolerance of SmofKabiven® versus Kabiven. The primary safety assessment is the relative reduction of the individual Model of End Stage Liver Disease (MELD) score at the final visit versus baseline (Day -1) and the secondary end point includes clinical laboratory evaluation, reported adverse events, vital signs, physical examination and number of days on PN for each of the study drugs |