NCT04094038

Brief Summary

Protein-energy wasting (PEW), a hypercatabolic state characterized by loss of muscle mass and fuel reserves, is highly prevalent in hemodialysis patients. Nutritional status and body composition are closely linked to morbidity, mortality and quality of life. Lean tissue mass (LTM) appears to be the best read-out for the association between nutritional status and outcomes. Intradialytic parenteral nutrition (IDPN) is occasionally used with the aim to reduce loss of LTM, but its efficacy has not been established. The goal of this study is to study the effect of IDPN on changes in LTM in hemodialysis patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2019

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

September 12, 2019

Last Update Submit

February 10, 2026

Conditions

End Stage Renal DiseaseHemodialysis ComplicationMalnutritionSarcopenia

Outcome Measures

Primary Outcomes (1)

  • Change in lean tissue mass

    Measured by body composition monitor (BCM)

    16 weeks

Secondary Outcomes (9)

  • Skeletal muscle quality index (SMQI)

    16 weeks

  • Change in adipose tissue mass from baseline

    16 weeks

  • Change in hand grip strength from baseline

    16 weeks

  • Change in kidney disease quality of life (KDQoL-36) energy/fatigue scale from baseline

    16 weeks

  • Change in kidney disease quality of life (KDQoL-36, overall health rating) from baseline

    16 weeks

  • +4 more secondary outcomes

Other Outcomes (3)

  • Subjective global assessment (SGA)

    16 weeks

  • Change in serum albumin concentration

    16 weeks

  • Appetite

    16 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Intradialytic parenteral nutrition three times weekly during 16 weeks

Drug: Olimel N12

Placebo

PLACEBO COMPARATOR

5% glucose three times weekly during 16 weeks

Drug: Glucose IV

Interventions

Olimel N12DRUG

A mixture of glucose, lipids, amino acids.

Intervention
Glucose IVDRUG

Glucose 5%

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing chronic hemodialysis

You may not qualify if:

  • Life expectancy \< 6 months
  • Planned kidney transplant within 4 months
  • Severe overhydration leading to respiratory insufficiency
  • Parenteral nutrition within four weeks prior to screening
  • Severe hepatic insufficiency
  • Pregnancy
  • Unipolar pacemaker with a very low sensitivity threshold
  • Active treatment for infection
  • Acute myocardial infarction
  • Circulatory shock
  • Hypersensitivity for any Olimel N12 ingredient or excipient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erasmus MC

Rotterdam, Netherlands

Location

Franciscus Gasthuis & Vlietland

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Kidney Failure, ChronicMalnutritionSarcopenia

Interventions

1-((2-hydroxyethyl)amino)-2-amino-1,2-dideoxyglucose triphenyltin(IV)

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • Ewout J Hoorn, MD PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2019

First Posted

September 18, 2019

Study Start

September 16, 2019

Primary Completion

April 2, 2024

Study Completion

July 1, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations

NL(2)