End Stage Renal DiseasePhase 4NCT04094038
The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients
A Phase 4 study testing Olimel N12 and Glucose IV in people with End Stage Renal Disease and Malnutrition, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Malnutrition, Sarcopenia
- What is being tested?
- Olimel N12 and Glucose IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 2 sitesNetherlands
- Study dates
- 16 Sep 2019to Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing chronic hemodialysis
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Erasmus MC
Rotterdam
Franciscus Gasthuis & Vlietland
Rotterdam
About this study
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.
- Being tested
- Olimel N12, Glucose IV
- Medical subject headings
- Kidney Failure, Chronic, Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olimel N12Drug
A mixture of glucose, lipids, amino acids.
Glucose IVDrug
Glucose 5%
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intradialytic parenteral nutrition three times weekly during 16 weeks Receives: Drug: Olimel N12 |
| Placebo | Placebo comparator | 5% glucose three times weekly during 16 weeks Receives: Drug: Glucose IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean tissue mass
Measured by body composition monitor (BCM)
Measured: 16 weeks
Secondary outcomes (9)
Skeletal muscle quality index (SMQI)
Assessed by muscle ultrasound
Measured: 16 weeks
Change in adipose tissue mass from baseline
Measured: 16 weeks
Change in hand grip strength from baseline
Measured by hand dynamometer, expressed as percentile of reference (by age and gender)
Measured: 16 weeks
Change in kidney disease quality of life (KDQoL-36) energy/fatigue scale from baseline
Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (energy/fatigue scale, 0-100, higher is better)
Measured: 16 weeks
Change in kidney disease quality of life (KDQoL-36, overall health rating) from baseline
Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (0-100, higher is better)
Measured: 16 weeks
Positive and negative affect
Assessed by Positive and Negative Affect Schedule (PANAS, 0-100, higher is better)
Measured: 16 weeks
Change in phase angle from baseline
Assessed by Body Composition Monitor (BCM)
Measured: 16 weeks
Change in body weight from baseline
Measured: 16 weeks
Change in serum prealbumin concentration from baseline
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start16 Sep 2019
- Primary completion2 Apr 2024
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Ewout Hoorn, Erasmus Medical Center
- Investigators
- Ewout J Hoorn, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094038
- Sponsor's protocol ID
- IDPN1
- Other IDs
- 2018-003899-13, NL65803.078.18, MEC-2018-1452, 2018
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2019
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04094038
- Acronym / sponsor ID
- IDPN1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Sep 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Olimel N12Intradialytic parenteral nutrition three times weekly during 16 weeks |
| Placebo | Placebo comparator | Drug: Glucose IV5% glucose three times weekly during 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing chronic hemodialysis
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Olimel N12A mixture of glucose, lipids, amino acids. | Drug | Intervention |
| Glucose IVGlucose 5% | Drug | Placebo |
Primary outcome
Change in lean tissue mass
Time frame: 16 weeks
Measured by body composition monitor (BCM)
9 secondary outcomes
Skeletal muscle quality index (SMQI)
Time frame: 16 weeks
Change in adipose tissue mass from baseline
Time frame: 16 weeks
Change in hand grip strength from baseline
Time frame: 16 weeks
Change in kidney disease quality of life (KDQoL-36) energy/fatigue scale from baseline
Time frame: 16 weeks
Change in kidney disease quality of life (KDQoL-36, overall health rating) from baseline
Time frame: 16 weeks
Positive and negative affect
Time frame: 16 weeks
Change in phase angle from baseline
Time frame: 16 weeks
Change in body weight from baseline
Time frame: 16 weeks
Change in serum prealbumin concentration from baseline
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ewout J Hoorn, MD PhD principal investigator
Erasmus Medical Center
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 Olimel N12 and Glucose IV in people with End Stage Renal Disease and Malnutrition, run by Erasmus Medical Center at 2 sites in Netherlands.
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 1 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in lean tissue mass (time frame: 16 weeks). 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 12 Feb 2026.