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CTRI Number  CTRI/2014/06/004665 [Registered on: 12/06/2014] 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® Peripheral (to be registered in India) in comparison to Kabiven Peripheral (already marketed in India) in patients with gastrointestinal disorders requiring parenteral nutrition 
Scientific Title of Study   Safety and local tolerance of SmofKabiven® Peripheral versus Kabiven® Peripheral: An assessor-blinded, randomised, controlled, multi-centre, non-inferiority study in adult patients with gastrointestinal disorders requiring parenteral nutrition 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SMKV-009-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  
Name  Address 
NIL  NIL 
 
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 Anil Kumar Agarwal   G.B. Pant Hospital  Department of Gastrointestinal Surgery and Liver Transplant, Jawaharlal Nehru Marg, New Delhi - 110002.
New Delhi
DELHI 		 9718599261

anilagarwal@outlook.com 
Dr Kona S Lakshmi Kumari  Global Hospital  Global Hospital, 6-1-1070/1 to 4, Lakdi-ka-pool, Telangana State, Hyderabad-500004
Hyderabad
ANDHRA PRADESH 		 9849713853

lakshmi.kona@yahoo.com 
Dr Parimal S Lawate  Jehangir Clinical Development Centre Pvt. Ltd, Jehangir Hospital Premises   Department of gastroenterology, 32 Sassoon Road, Pune – 411001 Maharashtra
Pune
MAHARASHTRA 		 9822028559

parimallawate@hotmail.com 
Dr AR Nitin Rao  M.S. Ramaiah Medical College and Hospitals   Department of Surgical Gastroenterology,New BEL Road, MSRIT Post, Bangalore – 560054
Bangalore
KARNATAKA 		 9880462155

nitrao@gmail.com 
Dr Sanjoy Mandal  Medica Super speciality   Department of Gastroenterology, 127 EM Bypass, Mukundapur, Kolkata-700099, West Bengal
Kolkata
WEST BENGAL 		 9836066320

drsanjoymandal@gmail.com 
Dr Dinesh H  Mysore Medical college and Research Institute  Department of Surgery, Mysore Medical College & Research Institute, Irwin road, Mysore-570001
Mysore
KARNATAKA 		 9448089500

drdinesh70@gmail.com 
Dr Ajay Sharma   Sawai Man Singh (SMS) Hospital   Department of Surgical Gastroenterology, JLN Marg, Jaipur – 302004, Rajasthan
Jaipur
RAJASTHAN 		 9314925742

asharmasgpgi@rediffmail.com 
Dr Hasmukh Vora  Sheth Vadilal Sarabhai Hospital  Department of Gastroenterology, Near Town Hall, Paldi Road, Ellis Bridge, Ahmedabad - 380006
Ahmadabad
GUJARAT 		 9824047486

hbvora@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Clinical Research Ethics Committee Medica Super Specialty Hospital  Approved 
Ethics Committee, Mysore Medical College & Research Institute  Approved 
Institutional Ethics Committee Maulana Azad Medical College and Associated Hospitals  Approved 
Institutional Ethics Committee, Smt. NHL Municipal Medical College, (NHLIEC)  Approved 
Institutional Ethics Committee-Global Hospitals  Approved 
Jehangir clinical development centre, Institutional review board  Approved 
M.S. Ramaiah Medical College and Hospitals Ethics Committee-   Approved 
Office of Ethics Committee of SMS Medical College and Attached Hospitals, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Adult patients with gastrointestinal disorders requiring parenteral nutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Kabiven® Peripheral emulsion for infusion   Kabiven® Peripheral emulsion for infusion (Fresenius Kabi AB, Uppsala, Sweden; referred to as “Kabiven Peripheral”); Active ingredients: essential, conditionally essential and non-essential amino acids, glucose, electrolytes and soy bean oil. Control product will be continuously infused via use of standardised peripheral venous catheters over 4-7 days at individualized daily doses Target: provision of 23-27 kcal/kg body weight/day  
Intervention  SmofKabiven® Peripheral emulsion for infusion  SmofKabiven® Peripheral 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 continuously infused via use of standardised peripheral venous catheters over 4-7 days at individualized daily doses Target: provision of 23-27 kcal/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 requires PN due to a gastrointestinal disorder or after elective major abdominal surgery (major abdominal surgery includes 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. MELD score ≥7 and ≤29
4. Patient is expected to require PN for a minimum of 4 and maximum of 7 consecutive days
5. Patient is expected to receive ≥70 % of the individual energy demand by PN for a minimum of 4 days
6. Age between 18 and 65 years
7. BMI ≥16 and ≤35 kg/m2
8. Patient is capable to give Informed Consent
9. 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. Acute organ transplantations (liver, pancreas, small bowel, kidney)
3. 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)
4. Patient is expected to receive more than 30% of the individual energy demand by ON/EN during the first 4 days of treatment
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. Severe hyperlipidaemia
15. Hyperhydration or fluid overload and/or pulmonary oedema
16. Uncontrolled hyperglycaemia
17. Pathologically elevated serum levels of any of the included electrolytes
18. Haemophagocytic syndrome
19. Any serious or clinically significant condition that would preclude participation in the study (in the opinion of the investigator)
20. Patient is pregnant or lactating and intends to continue breast-feeding
21. Inadequate presentation or condition of the peripheral veins (dorsal hand, forearm, cubital veins)
22. 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
23. Skin alterations that could potentially interfere with adequate assessment of local skin reactions. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
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 (value at Screening).
The MELD score is a composite score combiningthe 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 including local vein and skin reactions
Severity,seriousness,clinical relevance,relatedness and outcome of AEs
Various Laboratory variables at Pre surgery versus final visit lab value
Total daily severity score (TSS) of local vein and local skin reactions assessed from Day 1 (baseline) to last day of vein inspection
Vital signs
Number of days on PN for each of the study drugs,
volume administered daily allowing to calculate delivered calories

 		 Pre surgery versus final visit lab value
From Day 1 (baseline) to the last day of vein inspection 
 
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 study will be a prospective, randomized, controlled, assessor blinded, multi-centre, non-inferiority clinical trial assessing the safety of the SmofKabiven® Peripheral versus Kabiven® Peripheral and also to assess the the local vein tolerance of the study drugs. The primary safety assessment will be the relative reduction of the individual Model of End Stage Liver Disease (MELD) score at the final visit versus baseline (Day -1).The MELD score is a combined surrogate marker for hepatic and renal function and the secondary end point includes clinical laboratory evaluation, reported adverse events, vital signs, physical examination, the total severity score (TSS) of local vein- and local skin reactions assessed from Day 1 to the last day of vein inspection and number of days on PN for each of the study drugs.

 
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