Chronic Kidney DiseasePhase 2AL-EN-PHEDNCT01946841
Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life
A Phase 2 study testing RealDiet®Renal in people with Chronic Kidney Disease and Renal Failure Chronic Requiring Hemodialysis, run by Lactalis at 1 site in France.
Trial summary
The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis, Severe Malnutrition
- What is being tested?
- RealDiet®Renal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Jul 2014
- Phase
- Phase 2
- 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
- Chronic kidney disease patient on hemodialysis for at least 3 months, with a minimum of three hemodialysis sessions of 4 hours per week
- Patients aged 18 years
- Written, free and informed consent given by the Patient
- Patient insured under the social security system or equivalent
- Patients who did not receive enteral nutrition during the 3 months preceding inclusion ; taking an oral nutritional supplement, or per-dialytic parenteral nutrition or total parenteral nutrition is not a criterion of non-inclusion
- Patient in a state of malnutrition
Show all 17Show fewer
- defined by the presence of at least 3 out of 5 of the following criteria :
- weight loss greater than 10% observed in the last six months
- serum albumin <35 g / l
- serum Prealbumin <300 mg / l
- BMI <20
- NPNA <1 g / kg / day for 2 consecutive months
- and
- presenting
- food intake <20 kcal / kg / day or
- failure of other nutritional care methods, namely, oral nutritional supplements and / or peridialytic parenteral nutrition, or total parenteral nutrition
- lack of compliance after one month, to the nutritional care methods mentioned above. • Patients for whom the decision to prescribe enteral feeding was previously taken
Who cannot join
- Patients with a history of intolerance to enteral feeding
- Index Kt/Veq (balanced) < or = 1.2 or index Kt/Vsp (single pool) < or = 1.4 according to the method used
- Patients with a disease compromising the short-term (4-6 months) prognosis (cancer or other disease in the terminal phase)
- Pregnant Patient
- Patient with a known allergy to at least one of the following : milk protein, soy, fish
- Patient whose digestive tract is not functional or patient in shock
- Patient protected under guardianship
- Patient in exclusion period after participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.
The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.
- Conditions
- Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis, Severe Malnutrition, Tolerance, Quality of Life, Activity
- Being tested
- RealDiet®Renal
- Keywords
- Chronic kidney disease, Hemodialysis, Severe malnutrition, Enteral nutrition
- Medical subject headings
- Renal Insufficiency, Chronic, Malnutrition, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RealDiet®RenalDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| RealDiet®Renal enteral nutrition | Experimental | Not described Receives: Dietary Supplement: RealDiet®Renal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of serum prealbumin and albumin.
Evaluate during 3 months specific enteral nutrition (SEN) treatment, and 3 months after treatment interruption, the effects of the study product on the evolution of serum prealbumin and albumin.
Measured: 6 months
Secondary outcomes (3)
Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment.
Measured: 6 months
Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment.
Measured: 6 months
Evolution of tolerance of study product during 3 months of enteral nutrition.
Measured: 3 mois
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: No Patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lactalis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinact
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946841
- Sponsor's protocol ID
- LRD - 2013 - ALENPHED
- Acronym
- AL-EN-PHED
- Status last verified
- Sep 2013
- First submitted
- 6 Aug 2013
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.
- ClinicalTrials.gov ID
- NCT01946841
- Acronym / sponsor ID
- AL-EN-PHED / LRD - 2013 - ALENPHED
- Conditions
- Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis, Severe Malnutrition, Tolerance, Quality of Life, Activity
- Keywords
- Chronic kidney disease, Hemodialysis, Severe malnutrition, Enteral nutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Patient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LactalisIndustry (pharma, biotech, devices)
- Collaborators
- Clinact
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Sep 2013 (estimated)
- 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.
The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RealDiet®Renal enteral nutrition | Experimental | Dietary Supplement: RealDiet®Renal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Chronic kidney disease patient on hemodialysis for at least 3 months, with a minimum of three hemodialysis sessions of 4 hours per week
- Patients aged 18 years
- Written, free and informed consent given by the Patient
- Patient insured under the social security system or equivalent
- Patients who did not receive enteral nutrition during the 3 months preceding inclusion ; taking an oral nutritional supplement, or per-dialytic parenteral nutrition or total parenteral nutrition is not a criterion of non-inclusion
Key exclusion criteria (8 listed)
- Patients with a history of intolerance to enteral feeding
- Index Kt/Veq (balanced) < or = 1.2 or index Kt/Vsp (single pool) < or = 1.4 according to the method used
- Patients with a disease compromising the short-term (4-6 months) prognosis (cancer or other disease in the terminal phase)
- Pregnant Patient
- Patient with a known allergy to at least one of the following : milk protein, soy, fish
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 |
|---|---|---|
| RealDiet®Renal | Dietary supplement | RealDiet®Renal enteral nutrition |
Primary outcome
Evolution of serum prealbumin and albumin.
Time frame: 6 months
Evaluate during 3 months specific enteral nutrition (SEN) treatment, and 3 months after treatment interruption, the effects of the study product on the evolution of serum prealbumin and albumin.
3 secondary outcomes
Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment.
Time frame: 6 months
Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment.
Time frame: 6 months
Evolution of tolerance of study product during 3 months of enteral nutrition.
Time frame: 3 mois
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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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 Phase 2 study testing RealDiet®Renal in people with Chronic Kidney Disease and Renal Failure Chronic Requiring Hemodialysis, run by Lactalis 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 17 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: withdrawn, as of the sponsor's last update on 17 Apr 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 serum prealbumin and albumin. (time frame: 6 months). 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 17 Apr 2015.