CTRI/2025/07/091425 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On:
31/08/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A Study to Assess the Safety of Addaven in Adult Patients Needing Intravenous Nutrition After Surgery
Scientific Title of Study
An Open-label, Prospective, Single-arm, Multi-center, Phase IV Study to Assess the
Safety of Addaven in Adult Subjects Requiring Parenteral Nutrition After Surgery
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ADAV-007-CP4, Final Version 3.0/ 19 Mar 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Antaryami Maharana
Designation
GM-Medical Affairs and PV
Affiliation
Abiogenesis Clinpharm Private Limited
Address
2nd Floor Plot No. 69, 8-2-248-1-7-69, Nagarjuna Hills,
Punjagutta, Hyderabad
Hyderabad TELANGANA 500082 India
Phone
7702186021
Fax
Email
antaryami@abiogenesisclinpharm.com
Details of Contact Person Scientific Query
Name
Dr Sadanand Kulkarni
Designation
Head-Medical, Regulatory, Vigilance, Quality (South Asia)
Affiliation
Fresenius Kabi India Pvt Ltd
Address
9th Floor, AP 81, S. No. 83,
North Main Road, Mundhwa, Pune-411036, Maharashtra, India
Pune MAHARASHTRA 411036 India
Phone
9923002857
Fax
Email
Sadanand.Kulkarni@fresenius-kabi.com
Details of Contact Person Public Query
Name
Dr Sadanand Kulkarni
Designation
Head-Medical, Regulatory, Vigilance, Quality (South Asia)
Affiliation
Fresenius Kabi India Pvt Ltd
Address
9th Floor, AP 81, S. No. 83,
North Main Road, Mundhwa, Pune-411036, Maharashtra, India
Pune MAHARASHTRA 411036 India
Phone
9923002857
Fax
Email
Sadanand.Kulkarni@fresenius-kabi.com
Source of Monetary or Material Support
Fresenius Kabi India Pvt. Ltd.
A-3, MIDC, Ranjangaon Ganpati,
Tal. Shirur, Dist.- Pune- 412220
Maharashtra, India
Basavatarakam Indo-American Cancer Hospital and Research Institute
Road no.10, Banjara Hills, Hyderabad, Telangana-500034 Hyderabad TELANGANA
04023550015
drsujit888@gmail.com
Dr Prem Prakash
Indira Gandhi Institute of Medical Sciences
Room number 6, 1st floor, Department of General Surgery, Indira Gandhi Institute of Medical Sciences, Allahabad bank, Bailey Rd, Sheikhpura, Patna, Bihar 800014 Patna BIHAR
9801276237
drpremprakash01@gmail.com
Dr Abhijit Chandra
King Georges Medical University
DEPARTMENT OF SURGICAL, GASTROENTEROLOGY, King Georges Medical university GROUND FLOOR, PHASE 1 SHATABDI BUILDING.
CHOWK, Lucknow
UTTAR PRADESH, 226003, India Lucknow UTTAR PRADESH
05222258660
abhijitchandra@hotmail.com
Dr Anand Marutirao Nikalje
MGM Medical College and Hospital
Dept of Medicine,7th Floor, MGM Medical College and Hospital, Gate No. 2, MGM Campus, N-6, CIDCO., Aurangabad, MAHARASHTRA, India Aurangabad MAHARASHTRA
9822496190
dranandnikalje68@gmail.com
Dr Athira Gopinathan
SRM Medical College Hospital
Room no.4, Dept. of Surgery, SRM Medical College Hospital and Research Centre, Kattankulathur, Chengalpet-603203 TAMIL NADU, 603203, India Chennai TAMIL NADU
Institutional Ethics Committee SRM Medical College Hospital & Research Centre, Kattankulathur - 603 203, Chengalpattu, Tamil Nadu, India
Approved
Institutional Ethics Committee, IGIMS, Sheikhpura Indira Gandhi Institute of Medical Sciences Sheikhpura Raja Bazar Patna Patna Bihar - 800014 India
Approved
Institutional Ethics Committee, King Georges Medical University, Lucknow, Uttar Pradesh-226003, India
Approved
Institutionl Ethics Committee - BIACH & RI
Approved
MGM ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECT MGM Medical College and Hospital N-6 , CIDCO Aurangabad, Maharashtra - 431003 India
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Addaven
Addaven, concentrate for solution for infusion; a mixture of 9 trace elements
(chromium, copper, iron, manganese, iodine, fluoride, molybdenum,
selenium, zinc), One ampoule (10 mL) is added aseptically to a Three-Chamber Bag (3CB) parenteral nutrition solution and administered intravenously once daily for 4 consecutive days in post-operative adult patients.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Subjects of either sex, above or equal 18 to below or equal 65 years of age
2. A voluntarily given informed consent form (ICF) from the subject, or
legally acceptable representative (in case the subject is not able)
3. Subjects from Indian population
4. Subjects with an indication for PN during the postoperative period, with an anticipated duration of 4 consecutive days—subjects scheduled to undergo elective major abdominal surgery, including surgery for cancer and non-cancer reasons (e.g., oesophageal resection, gastrectomy, pancreatoduodenectomy, partial pancreatectomy, small bowel resection, colon resection surgery, etc.)
5. Body mass index above or equal to 16 or below or equal to 30 kg/m²
ExclusionCriteria
Details
1. Subjects with known allergy or hypersensitivity to the active substances or any excipients of the study drug
2. Congestive cardiac failure, or other forms of cardiopulmonary
instability, e.g., cardiac arrhythmias, conditions associated with low cardiac output, hypoxemia with or without respiratory failure, shock, or blood pressure outside its normal range
3. Acute or chronic kidney disease in need of renal replacement therapy (acute kidney injury 2-3 and/or KDIGO Chronic Kidney Disease stages 4-5)
4. Conditions with total biliary obstruction, like gallstones, cysts, cirrhosis, tumors, liver/biliary tract trauma, among others
5. Hepatic failure, defined as impaired liver synthetic and metabolic function
6. Wilson’s disease
7. Known or suspected hemochromatosis, hemosiderosis
8. Known or suspected pregnancy at the time of enrollment
9. Breastfeeding mothers during the study period
10. Participation in other clinical trial(s) during this study, or within the previous 4 weeks of its start
11. Subjects with known or suspected alcohol or drug abuse
12. Subjects taking any oral supplements or any beverages containing high amounts of TEs 1 week before and during the study
13. Any other clinical condition, which, in the opinion of the Investigator, could interfere with the study protocol, or affect subjects’ safety in the study
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Incidence of Treatment Treatment-Emergent Adverse Events (TEAEs adverse events (AEs) occurring after the onset of infusion of the first study drug dose till next calendar day after the last study drug dose)
From Day 1 of Addaven infusion until one calendar day after the last infusion (i.e., Day 5 or Day 6)
Screening, enrollment and from Day 1 to Day 4; final assessment on Day 5/6
Target Sample Size
Total Sample Size="188" Sample Size from India="188" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a phase IV, open-label, prospective, single-arm, multicenter study to evaluate the safety of Addaven in adult patients requiring parenteral nutrition after surgery. Addaven is a trace element concentrate containing chromium, copper, iron, manganese, iodine, fluoride, molybdenum, selenium, and zinc. The study aims to assess the incidence of treatment-emergent adverse events and adverse drug reactions following administration of Addaven for four consecutive days as part of postoperative parenteral nutrition. Approximately 188 subjects undergoing elective major abdominal surgery will be enrolled across multiple sites in India. Safety assessments will include adverse event monitoring, changes in vital signs, and clinical laboratory evaluations.