Renal InsufficiencyNCT04445558
Study of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients
A study testing oral nutritional supplementation and intradialytic parenteral nutrition in people with Renal Insufficiency, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- oral nutritional supplementation and intradialytic parenteral nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2020to 4 Jun 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with renal failure, on hemodialysis for at least 12 months;
- Hemodialysis patient in 3 weekly sessions on a device with a standard permeability membrane (polysulfone, polyethersulfone or polyartylethersulfone type);
- Malnourished patient, on intradialytic parenteral nutrition for at least 6 months;
- Patient who may benefit, according to the doctor, from a change in dialysis and nutrition strategy:
- Patient who signed an informed consent form to participate in the study
Who cannot join
- Known allergy to PEPA® ;
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- Patient with a chronic infection in progress;
- Patient with life expectancy <6 months according to the investigator;
- Inability to understand information related to the study (linguistic, psychological, cognitive reason, etc.);
- Pregnant woman or likely to be (of childbearing age, without effective contraception) or breastfeeding;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- Patient not benefiting from a social security scheme.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Two Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic End-stage Renal Disease Patients Dependent on Intradialytic Parenteral Nutrition
Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.
Read the detailed description
The study proposes to compare the nutritional state after 6 months of dialysis with standard membrane associated with intradialytic parenteral nutrition (retrospective phase) with the nutritional state after 6 months of dialysis with high permeability membrane associated with oral nutritional supplementation (prospective phase).
- Conditions
- Renal Insufficiency
- Being tested
- oral nutritional supplementation, intradialytic parenteral nutrition
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral nutritional supplementationDietary supplement
Adjunction of oral nutritional supplementation
intradialytic parenteral nutritionDietary supplement
Adjunction of intradialytic parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Membrane PEPA® | Experimental | Patient will use the membrane PEPA® for the dialysis Receives: Dietary Supplement: oral nutritional supplementation |
| Standard membrane of dialysis | Active comparator | Patient will use a standard membrane for the dialysis Receives: Dietary Supplement: intradialytic parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the nutritional status
The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level.
Measured: Month 6
Secondary outcomes (3)
Evolution of nutritional assessment
Evolution of the percentage of weight loss (in Kg)
Measured: Month 6
Appearance of adverse events
Incidence and characteristics of adverse events / effects
Measured: Month 6
Measure of the Quality of life
Evolution of the quality of life, evaluated by the EORTC QLQ-C30 questionnaire of the quality of life with 28 questions with 4 possible answers from "not at all" to "a lot of"
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start21 Jul 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445558
- Sponsor's protocol ID
- 2020-A01267-32
- Status last verified
- Jan 2022
- First submitted
- 19 Jun 2020
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Two Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic End-stage Renal Disease Patients Dependent on Intradialytic Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT04445558
- Acronym / sponsor ID
- 2020-A01267-32
- Conditions
- Renal Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 24 Jun 2020 (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.
Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.
Detailed description
The study proposes to compare the nutritional state after 6 months of dialysis with standard membrane associated with intradialytic parenteral nutrition (retrospective phase) with the nutritional state after 6 months of dialysis with high permeability membrane associated with oral nutritional supplementation (prospective phase).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Membrane PEPA® | Experimental | Dietary Supplement: oral nutritional supplementationPatient will use the membrane PEPA® for the dialysis |
| Standard membrane of dialysis | Active comparator | Dietary Supplement: intradialytic parenteral nutritionPatient will use a standard membrane for the dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with renal failure, on hemodialysis for at least 12 months;
- Hemodialysis patient in 3 weekly sessions on a device with a standard permeability membrane (polysulfone, polyethersulfone or polyartylethersulfone type);
- Malnourished patient, on intradialytic parenteral nutrition for at least 6 months;
- Patient who may benefit, according to the doctor, from a change in dialysis and nutrition strategy:
- Patient who signed an informed consent form to participate in the study
Key exclusion criteria (8 listed)
- Known allergy to PEPA® ;
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- Patient with a chronic infection in progress;
- Patient with life expectancy <6 months according to the investigator;
- Inability to understand information related to the study (linguistic, psychological, cognitive reason, etc.);
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 |
|---|---|---|
| oral nutritional supplementationAdjunction of oral nutritional supplementation | Dietary supplement | Membrane PEPA® |
| intradialytic parenteral nutritionAdjunction of intradialytic parenteral nutrition | Dietary supplement | Standard membrane of dialysis |
Primary outcome
Evolution of the nutritional status
Time frame: Month 6
The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level.
3 secondary outcomes
Evolution of nutritional assessment
Time frame: Month 6
Appearance of adverse events
Time frame: Month 6
Measure of the Quality of life
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral nutritional supplementation and intradialytic parenteral nutrition in people with Renal Insufficiency, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evolution of the nutritional status (time frame: Month 6). 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 5 Jan 2022.