MalnutritionPhase 4NCT03481894
Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age
A Phase 4 study testing Kabiven® and Compounded standard parenteral nutrition in people with Malnutrition, run by Fresenius Kabi at 2 sites in United States.
Trial summary
Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN) administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to meet nutritional needs. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Kabiven® and Compounded standard parenteral nutrition
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2018to Mar 2021
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients 2 to 16 years of age
- Patients who require at least 80% of their caloric intake as PN at study start, and in whom an indication for PN is expected for at least 5 days
- Patients who require a central venous line to receive PN or already have a central venous line in place for other reasons
- Written informed consent from legal representative(s)
Who cannot join
- Known hypersensitivity to egg, soybean proteins, peanut proteins, corn or corn products, or to any of the active substances or excipients
- Severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration >1,000 g/dL).
- Inborn errors of amino acid metabolism
- Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support)
- Hemophagocytic syndrome.
- PN in the last 7 days prior to study enrollment.
Show all 12Show fewer
- Need for chronic PN before study start
- Liver enzymes (either AST, ALT, GGPT), or direct bilirubin exceeding 2 x upper limit of normal range
- Pathologically altered level of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate) unless corrected prior to the start of study treatment
- Pathologically altered blood pH, or oxygen saturation, or carbon dioxide unless corrected prior to the start of study treatment
- Pregnancy or lactation
- Participation in another clinical study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Chicago Medical Center
Chicago, Illinois, 60637
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Prospective, Randomized, Open-Label, Parallel-Group, Active-Controlled, Multicenter Study to Assess Safe and Effective Doses of Kabiven® in Pediatric Patients 2 to 16 Years of Age
Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN) administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to meet nutritional needs.
- Conditions
- Malnutrition
- Being tested
- Kabiven®, Compounded standard parenteral nutrition
- Keywords
- Parenteral nutrition, Malnutrition, Pediatrics, nutritional needs
- Medical subject headings
- Malnutrition, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kabiven®Drug
Also called Kabiven® for intravenous use (investigational drug)
Infusion should start at a low dose (i.e., 12.5 to 25 mL/kg, corresponding to 10.6 to 21.2 kcal/kg/day, 0.49 to 0.98 g lipids/kg/day, 0.41 to 0.83 g amino acids/kg/day and 1.2 to 2.4 g dextrose/kg/day) followed by stepwise increase to the individual target for PN calories.
The daily dose of the study PN should be infused at a constant rate over 20 to 24 hours.
Route of Administration: Infusion into a central vein. Duration of Treatment: Study treatment will last for a minimum of 5 and a maximum of 8 consecutive days. Study treatment will be stopped if oral and/or enteral intake covers 80% or more of caloric requirements. If the indication for PN continues after 8 study days, PN will continue per normal institution policy.
Compounded standard parenteral nutritionDrug
Also called Compounded standard parenteral nutrition (control drug)
Infusion should start at a low dose (i.e., 12.5 to 25 mL/kg, corresponding to 10.6 to 21.2 kcal/kg/day, 0.49 to 0.98 g lipids/kg/day, 0.41 to 0.83 g amino acids/kg/day and 1.2 to 2.4 g dextrose/kg/day) followed by stepwise increase to the individual target for PN calories.
The daily dose of the study PN should be infused at a constant rate over 20 to 24 hours.
Route of Administration: Infusion into a central vein. Duration of Treatment: Study treatment will last for a minimum of 5 and a maximum of 8 consecutive days. Study treatment will be stopped if oral and/or enteral intake covers 80% or more of caloric requirements. If the indication for PN continues after 8 study days, PN will continue per normal institution policy.
| Study group | Role | What they receive |
|---|---|---|
| Kabiven® | Experimental | Kabiven is a sterile, hypertonic emulsion in a three chamber container. The separate chambers contain either amino acids with electrolytes, dextrose, or lipid injectable emulsion. Receives: Drug: Kabiven® |
| Compounded standard parenteral nutrition | Active comparator | The control drug will be compounded for each individual patient as prescribed by the physician. Compounding will be performed according to normal hospital procedure which meets the requirements of the United States Pharmacopeial Convention (USP) <797> "Pharmaceutical Compounding-Sterile Preparations". Receives: Drug: Compounded standard parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
All adverse events (AE)
Measured: After randomization until Day 9
Vital signs: blood pressure
Measured: Day 1 - 9
Vital signs: heart rate
Measured: Day 1 - 9
Vital signs: body temperature
Measured: Day 1 - 9
Vital signs: respiratory rate
Measured: Day 1 - 9
Vital signs: saturation of peripheral oxygen (spO2)
Measured: Days 1-9
Urine volume
Measured: Days 1-9
Change from baseline urea nitrogen on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline alanine aminotransferase (ALT) on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline aspartate aminotransferase (AST) on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline direct bilirubin on days 2, 5 and 9 on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline total bilirubin on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline gamma-glutamyl transpeptidase (GGTP) on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline alkaline phosphatase (ALP) on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline creatinine on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline electrolytes (sodium, potassium, magnesium, calcium, chloride, phosphate) on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline osmolarity on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline pH on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline glucose on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline triglycerides on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline cholesterol on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline lipase on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline amylase on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline total protein on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline c-reactive protein (CRP) on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline white blood cells (WBC) count on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline platelet count on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline red blood cells (RBC) count on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline hemoglobin (hgb) on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline Hematocrit (hct) on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline international normalized ratio (INR) on days 2, 5 and 9
Measured: Days 1, 2 (or if not done: Day 3), 5, 9
Nosocomial infection
Number of health care associated infections
Measured: After randomization until Day 9
Need for renal replacement therapy
Measured: Days 1-9
Duration of renal replacement therapy
Measured: Days 1-9
Need for mechanical ventilation
Measured: Days 1-9
Duration of mechanical ventilation
Measured: Days 1-9
Change from baseline body weight on days 5 and 9
Measured: Days 1, 5, 9
Change from baseline albumin on days 5 and 9
Measured: Days 1, 5, 9
Change from baseline prealbumin on days 5 and 9
Measured: Days 1, 5, 9
Change from baseline transferrin on days 5 and 9
Measured: Days 1, 5, 9
Change from baseline alpha linolenic acid on days 5 and 9
Measured: Days 1, 5, 9
Change from baseline linoleic acid on days 5 and 9
Measured: Days 1, 5, 9
Change from baseline arachidonic acid on days 5 and 9
Measured: Days 1, 5, 9
Change from baseline eicosatrienoic (mead) acid on days 5 and 9
Measured: Days 1, 5, 9
Change from baseline triene/tetraene ratio (Holman index) on days 5 and 9
Measured: Days 1, 5, 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: FDA released Fresenius Kabi from this post marketing requirement on 07/16/2019.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel D Lim, MD, Principal investigator, Children's Mercy Hospital, Kansas City, MO 64108
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481894
- Sponsor's protocol ID
- KABI-004-CP3
- Status last verified
- Sep 2019
- First submitted
- 3 Dec 2015
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Open-Label, Parallel-Group, Active-Controlled, Multicenter Study to Assess Safe and Effective Doses of Kabiven® in Pediatric Patients 2 to 16 Years of Age
- ClinicalTrials.gov ID
- NCT03481894
- Acronym / sponsor ID
- KABI-004-CP3
- Conditions
- Malnutrition
- Keywords
- Parenteral nutrition, Malnutrition, Pediatrics, nutritional needs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA released Fresenius Kabi from this post marketing requirement on 07/16/2019.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Mar 2018 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN) administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to meet nutritional needs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kabiven® | Experimental | Drug: Kabiven®Kabiven is a sterile, hypertonic emulsion in a three chamber container. The separate chambers contain either amino acids with electrolytes, dextrose, or lipid injectable emulsion. |
| Compounded standard parenteral nutrition | Active comparator | Drug: Compounded standard parenteral nutritionThe control drug will be compounded for each individual patient as prescribed by the physician. Compounding will be performed according to normal hospital procedure which meets the requirements of the United States Pharmacopeial Convention (USP) <797> "Pharmaceutical Compounding-Sterile Preparations". |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female patients 2 to 16 years of age
- Patients who require at least 80% of their caloric intake as PN at study start, and in whom an indication for PN is expected for at least 5 days
- Patients who require a central venous line to receive PN or already have a central venous line in place for other reasons
- Written informed consent from legal representative(s)
Key exclusion criteria (12 listed)
- Known hypersensitivity to egg, soybean proteins, peanut proteins, corn or corn products, or to any of the active substances or excipients
- Severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration >1,000 g/dL).
- Inborn errors of amino acid metabolism
- Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support)
- Hemophagocytic syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kabiven®Also: Kabiven® for intravenous use (investigational drug)Infusion should start at a low dose (i.e., 12.5 to 25 mL/kg, corresponding to 10.6 to 21.2 kcal/kg/day, 0.49 to 0.98 g lipids/kg/day, 0.41 to 0.83 g amino acids/kg/day and 1.2 to 2.4 g dextrose/kg/day) followed by stepwise increase to the individual target for PN calories. The daily dose of the study PN should be infused at a constant rate over 20 to 24 hours. Route of Administration: Infusion into a central vein. Duration of Treatment: Study treatment will last for a minimum of 5 and a maximum of 8 consecutive days. Study treatment will be stopped if oral and/or enteral intake covers 80% or more of caloric requirements. If the indication for PN continues after 8 study days, PN will continue per normal institution policy. | Drug | Kabiven® |
| Compounded standard parenteral nutritionAlso: Compounded standard parenteral nutrition (control drug)Infusion should start at a low dose (i.e., 12.5 to 25 mL/kg, corresponding to 10.6 to 21.2 kcal/kg/day, 0.49 to 0.98 g lipids/kg/day, 0.41 to 0.83 g amino acids/kg/day and 1.2 to 2.4 g dextrose/kg/day) followed by stepwise increase to the individual target for PN calories. The daily dose of the study PN should be infused at a constant rate over 20 to 24 hours. Route of Administration: Infusion into a central vein. Duration of Treatment: Study treatment will last for a minimum of 5 and a maximum of 8 consecutive days. Study treatment will be stopped if oral and/or enteral intake covers 80% or more of caloric requirements. If the indication for PN continues after 8 study days, PN will continue per normal institution policy. | Drug | Compounded standard parenteral nutrition |
Primary outcome
All adverse events (AE)
Time frame: After randomization until Day 9
Vital signs: blood pressure
Time frame: Day 1 - 9
Vital signs: heart rate
Time frame: Day 1 - 9
Vital signs: body temperature
Time frame: Day 1 - 9
Vital signs: respiratory rate
Time frame: Day 1 - 9
Vital signs: saturation of peripheral oxygen (spO2)
Time frame: Days 1-9
Urine volume
Time frame: Days 1-9
Change from baseline urea nitrogen on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline alanine aminotransferase (ALT) on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline aspartate aminotransferase (AST) on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline direct bilirubin on days 2, 5 and 9 on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline total bilirubin on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline gamma-glutamyl transpeptidase (GGTP) on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline alkaline phosphatase (ALP) on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline creatinine on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline electrolytes (sodium, potassium, magnesium, calcium, chloride, phosphate) on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline osmolarity on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline pH on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline glucose on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline triglycerides on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline cholesterol on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline lipase on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline amylase on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline total protein on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline c-reactive protein (CRP) on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline white blood cells (WBC) count on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline platelet count on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline red blood cells (RBC) count on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline hemoglobin (hgb) on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline Hematocrit (hct) on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Change from baseline international normalized ratio (INR) on days 2, 5 and 9
Time frame: Days 1, 2 (or if not done: Day 3), 5, 9
Nosocomial infection
Time frame: After randomization until Day 9
Number of health care associated infections
Need for renal replacement therapy
Time frame: Days 1-9
Duration of renal replacement therapy
Time frame: Days 1-9
Need for mechanical ventilation
Time frame: Days 1-9
Duration of mechanical ventilation
Time frame: Days 1-9
Change from baseline body weight on days 5 and 9
Time frame: Days 1, 5, 9
Change from baseline albumin on days 5 and 9
Time frame: Days 1, 5, 9
Change from baseline prealbumin on days 5 and 9
Time frame: Days 1, 5, 9
Change from baseline transferrin on days 5 and 9
Time frame: Days 1, 5, 9
Change from baseline alpha linolenic acid on days 5 and 9
Time frame: Days 1, 5, 9
Change from baseline linoleic acid on days 5 and 9
Time frame: Days 1, 5, 9
Change from baseline arachidonic acid on days 5 and 9
Time frame: Days 1, 5, 9
Change from baseline eicosatrienoic (mead) acid on days 5 and 9
Time frame: Days 1, 5, 9
Change from baseline triene/tetraene ratio (Holman index) on days 5 and 9
Time frame: Days 1, 5, 9
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel D Lim, MD principal investigator
Children's Mercy Hospital, Kansas City, MO 64108
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kabiven® and Compounded standard parenteral nutrition in people with Malnutrition, run by Fresenius Kabi at 2 sites in United States.
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 12 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: withdrawn, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All adverse events (AE) (time frame: After randomization until Day 9). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.