E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Malnutrition / Sarcopenia (loss of muscle mass) in hemodialyse patients. |
Ondervoeding / sarcopenie (verlies van spiermassa) bij hemodialyse patienten |
|
E.1.1.1 | Medical condition in easily understood language |
Malnutrition /loss of muscle mass in hemodialyse patients. |
Ondervoeding / verlies van spiermassa bij hemodialyse patienten |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study the effect of intradialytic parenteral nutrition (Olimel N9) on lean tissue Mass (LTM) assessed by Body Composition Monitor (BCM) in adult hemodialysis patients |
Het effect van intradialytische parenterale voeding op spiermassa bij volwassen hemodialysepatienten |
|
E.2.2 | Secondary objectives of the trial |
• Adipose Tissue Mass (ATM) assessed by Body Composition Monitor (BCM)
• Body weight
• Dry weight
• Phase Angel, assessed by Body Composition Monitor (BCM)
• Skeletal Muscle Quality Index (SMQI) assessed by ultrasound
• Subjective Global Assessment (SGA), 7 point scale
• Functionality assessed by hand grip strenght (HGS)
• Appetite, Numeric Rating Scale (NRS)
• Food intake assessed by 24-hours recall with global dietary history (calories and protein)
• Normalized protein nitrogen appearance (nPNA)
• Exercise, assessed by Activ8 and exercise diary
• Quality of Life: assessed by questionnaire KDQoL and PANAS
• Dialysis adequacy (KT/V)
• Serum C-reactive protein (CRP)
• Serum albumin
• Serum pre-albumin
• Serum bicarbonate
|
• Vetmassa
• Lichaamsgewicht
• Streefgewicht
• Fase hoek
• Spierkwaliteit (spierechografie)
• Subjective Global Assessment (SGA), 7 punts schaal
• Functionaliteit, gemeten met handknijp kracht
• Eetlust
• Voedingsinname (Energie en eiwit)
• Stikstofbalans
• Activiteitenpatroon
• Kwaliteit van leven
• Dialyse effectiviteit (KT/V)
• Serum C-reactive protein (CRP)
• Serum albumine
• Serum pre-albumine
• Serum bicarbonaat
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age: ≥ 18 years
• Hemodialysis, 3 times / week, minimum 3,5 hours / session.
|
Leeftijd: 18 jaar en ouder
Hemodialyse: 3x per week, minimal 3.5 uur / sessie |
|
E.4 | Principal exclusion criteria |
• Life expectancy < 6 months
• Planned kidney transplant within 4 months
• Active treatment for infection
• Pregnancy
• Parenteral nutrition for at least four weeks prior to screening
• Unipolar pacemaker with a very low sensitivity threshold
Regular exclusion criteria for the use of parenteral nutrition in hemodialysis patients:
• Severe overhydration leading to respiratory insufficiency.
• Hypersensitivity for any ingredient or excipients
• Severe hepatic insufficiency, total bilirubin > 20 µmol/l, ASAT + ALAT: > 3 times higher
than reference values.
• Acute phase of circulatory shock
• Acute myocardial infarction
• Severe sepsis
|
• Levensverwachting < 6 maanden
• Geplande niertransplantatie binnen 4 maanden
• Behandeling voor een infectie
• Zwangerschap
• Gebruik van parenterale voeding, langer dan 4 weken voor screening
• Unipolaire pacemaker met een zeer lage gevoeligheid
Reguliere exclusiecriteria voor parenterale voeding tijdens dialyse
• Ernstige overvulling
• Overgevoeligheid of allergie tegen een van de ingredienten.
• Ernstig leverfalen.
• Acute fase van shock
• Acute fase van hartstilstand
• Ernstige sepsis
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Muscle mass (lean tissue mass) |
spiermassa |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, after 1, 2 and 3 months, and 1 month after infusion |
Bij start, na 1, 2 en 3 maanden en 1 maand na stoppen van het infuus. |
|
E.5.2 | Secondary end point(s) |
Effects on body composition, nutritional status, dialysis characteristics an biochemical parameters. |
Effect op lichaamssamenstelling, voedingstoestand, dialyse parameters en bloeduitslagen |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, after 1, 2 and 3 months, and 1 month after infusion |
Bij start, na 1, 2 en 3 maanden en 1 maand na stoppen van het infuus. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Laatste bezoek van de laatste deelnemer |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |