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Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age

Primary Purpose

Malnutrition

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Kabiven®

Compounded standard parenteral nutrition

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring Parenteral nutrition, Malnutrition, Pediatrics, nutritional needs

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.
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

Sites / Locations

The University of Chicago Medical Center
Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kabiven®

Compounded standard parenteral nutrition

Arm Description

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.

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".

Outcomes

Primary Outcome Measures

All adverse events (AE)

Vital signs: blood pressure

Vital signs: heart rate

Vital signs: body temperature

Vital signs: respiratory rate

Vital signs: saturation of peripheral oxygen (spO2)

Urine volume

Change from baseline urea nitrogen on days 2, 5 and 9

Change from baseline alanine aminotransferase (ALT) on days 2, 5 and 9

Change from baseline aspartate aminotransferase (AST) on days 2, 5 and 9

Change from baseline direct bilirubin on days 2, 5 and 9 on days 2, 5 and 9

Change from baseline total bilirubin on days 2, 5 and 9

Change from baseline gamma-glutamyl transpeptidase (GGTP) on days 2, 5 and 9

Change from baseline alkaline phosphatase (ALP) on days 2, 5 and 9

Change from baseline creatinine on days 2, 5 and 9

Change from baseline electrolytes (sodium, potassium, magnesium, calcium, chloride, phosphate) on days 2, 5 and 9

Change from baseline osmolarity on days 2, 5 and 9

Change from baseline pH on days 2, 5 and 9

Change from baseline glucose on days 2, 5 and 9

Change from baseline triglycerides on days 2, 5 and 9

Change from baseline cholesterol on days 2, 5 and 9

Change from baseline lipase on days 2, 5 and 9

Change from baseline amylase on days 2, 5 and 9

Change from baseline total protein on days 2, 5 and 9

Change from baseline c-reactive protein (CRP) on days 2, 5 and 9

Change from baseline white blood cells (WBC) count on days 2, 5 and 9

Change from baseline platelet count on days 2, 5 and 9

Change from baseline red blood cells (RBC) count on days 2, 5 and 9

Change from baseline hemoglobin (hgb) on days 2, 5 and 9

Change from baseline Hematocrit (hct) on days 2, 5 and 9

Change from baseline international normalized ratio (INR) on days 2, 5 and 9

Nosocomial infection

Number of health care associated infections

Need for renal replacement therapy

Duration of renal replacement therapy

Need for mechanical ventilation

Duration of mechanical ventilation

Change from baseline body weight on days 5 and 9

Change from baseline albumin on days 5 and 9

Change from baseline prealbumin on days 5 and 9

Change from baseline transferrin on days 5 and 9

Change from baseline alpha linolenic acid on days 5 and 9

Change from baseline linoleic acid on days 5 and 9

Change from baseline arachidonic acid on days 5 and 9

Change from baseline eicosatrienoic (mead) acid on days 5 and 9

Change from baseline triene/tetraene ratio (Holman index) on days 5 and 9

Secondary Outcome Measures

Full Information

NCT ID

NCT03481894

First Posted

December 3, 2015

Last Updated

September 2, 2019

Sponsor

Fresenius Kabi

1. Study Identification

Unique Protocol Identification Number

NCT03481894

Brief Title

Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Withdrawn

Why Stopped

FDA released Fresenius Kabi from this post marketing requirement on 07/16/2019.

Study Start Date

March 2018 (Anticipated)

Primary Completion Date

March 2020 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fresenius Kabi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition

Keywords

Parenteral nutrition, Malnutrition, Pediatrics, nutritional needs

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Kabiven®

Arm Type

Experimental

Arm Description

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.

Arm Title

Compounded standard parenteral nutrition

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Kabiven®

Other Intervention Name(s)

Kabiven® for intravenous use (investigational drug)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Compounded standard parenteral nutrition

Other Intervention Name(s)

Compounded standard parenteral nutrition (control drug)

Intervention Description

Primary Outcome Measure Information:

Title

All adverse events (AE)

Time Frame

After randomization until Day 9

Title

Vital signs: blood pressure

Time Frame

Day 1 - 9

Title

Vital signs: heart rate

Time Frame

Day 1 - 9

Title

Vital signs: body temperature

Time Frame

Day 1 - 9

Title

Vital signs: respiratory rate

Time Frame

Day 1 - 9

Title

Vital signs: saturation of peripheral oxygen (spO2)

Time Frame

Days 1-9

Title

Urine volume

Time Frame

Days 1-9

Title

Change from baseline urea nitrogen on days 2, 5 and 9

Time Frame