Chronic Kidney FailurePhase 3AMERICANONCT02418065
Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)
A Phase 3 study testing training on ergonomic bicycle, Testosterone and Oral nutritional supplementation in people with Chronic Kidney Failure, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- training on ergonomic bicycle, Testosterone and Oral nutritional supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Apr 2017
- Phase
- Phase 3
- 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
- Hemodialysis patient since at least 6 month
- Patient aged 18 years or older
- Written consent to participate in the study
- No acute infection or hospitalization
- Opinion of Cardiologist saying there is no known evidence against the evaluation of the maximum exercise capacity
- Protein-energy wasting diagnosed if at least two of this characteristics are present
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- Serum albumin <3.8 g per 100 ml (Bromcresol Green)
- Serum prealbumin (transthyretin) <30mg per 100 ml
- Reduce body mass (BMI <23)
- Unintentional 10% weight loss over 6 months
- Lean body mass index < 10th percentile
Who cannot join
- Presence of comorbidity which compromising the survival within 6 month
- Unintentional low DEI <20 kcal kg_1 day_1
- HIV or HCV positive
- History of hormone dependent cancer
- Suspected or confirmed prostate cancer or breast carcinoma
- Known hypersensitivity for testosterone
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- Presence or history of hepatic tumor
- Inability to follow the rehabilitation program
- Inadequate dialysis dosage (<12 hours / week or Kt/V index< 1,2) Pregnant or planning pregnancy and lactating women during study period
- Adult patient protected by law
- Patient who don't sign his informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Dorothée BAZIN KARA
About this study
Official title: Multimodal Therapeutic Approach by Exercise, Oral Nutritional Supplementation, Omega 3 and Androgen in Undernourished Maintenance Hemodialysis Patients (AMERICANO)
The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.
Read the detailed description
The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.
- Conditions
- Chronic Kidney Failure
- Being tested
- training on ergonomic bicycle, Testosterone, Oral nutritional supplementation, n3 polyunsaturated fatty acid
- Keywords
- Physical exercises, Oral nutritional supplementation, Multimodal, Hemodialysis, Protein-Energy Wasting
- Medical subject headings
- Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training on ergonomic bicycleOther
TestosteroneDrug
Oral nutritional supplementationDrug
n3 polyunsaturated fatty acidDrug
| Study group | Role | What they receive |
|---|---|---|
| treated group | Experimental | testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle Receives: Other: training on ergonomic bicycle; Drug: Testosterone; Drug: Oral nutritional supplementation; Drug: n3 polyunsaturated fatty acid |
| control group | Other | oral nutritional supplementation Receives: Drug: Oral nutritional supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of physical endurance on bicycle
Physical endurance on bicycle at intermediate power between maximal power and ventilatory threshold power (Pmax+Pthreshold)/2
Measured: At months 3 and 15 after inclusion
Secondary outcomes (9)
Transthyrin serum concentration evolution
(Unit of Measure: g/L)
Measured: at day 1
Health-related quality of life assessment using SF-36 scale and KDQOL
Measured: at day 1
Karnofsky score
Measured: at ady 1
Maximal power on bicycle
Unit of Measure: Watt
Measured: at day 1
Nutritional parameters
weight (Kg)
Measured: at day 1
serum levels of albumin (g/L)
Measured: at day 1
determination of urea (mmol/L)
Measured: at day 1
determination of creatinine(µmol/L)
Measured: at 1 year
Body composition
(evaluated by bioimpedance)
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startDec 2013
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Human Nutrition Research Center Rhône-Alpes, Société Francophone Nutrition Clinique et Métabolisme, Nutricia, Inc.
- Responsible party
- Sponsor
- Investigators
- Noël CANO, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418065
- Sponsor's protocol ID
- CHU-0231
- Acronym
- AMERICANO
- Status last verified
- Jul 2016
- First submitted
- 3 Apr 2015
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
PubMed 32390133
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Therapeutic Approach by Exercise, Oral Nutritional Supplementation, Omega 3 and Androgen in Undernourished Maintenance Hemodialysis Patients (AMERICANO)
- ClinicalTrials.gov ID
- NCT02418065
- Acronym / sponsor ID
- AMERICANO / CHU-0231
- Conditions
- Chronic Kidney Failure
- Keywords
- Physical exercises, Oral nutritional supplementation, Multimodal, Hemodialysis, Protein-Energy Wasting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Human Nutrition Research Center Rhône-Alpes, Société Francophone Nutrition Clinique et Métabolisme, Nutricia, Inc.
- Study start
- Dec 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 16 Apr 2015 (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 aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.
Detailed description
The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treated group | Experimental | Other: training on ergonomic bicycle, Drug: Testosterone, Drug: Oral nutritional supplementation, Drug: n3 polyunsaturated fatty acidtestosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle |
| control group | Other | Drug: Oral nutritional supplementationoral nutritional supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Hemodialysis patient since at least 6 month
- Patient aged 18 years or older
- Written consent to participate in the study
- No acute infection or hospitalization
- Opinion of Cardiologist saying there is no known evidence against the evaluation of the maximum exercise capacity
Key exclusion criteria (11 listed)
- Presence of comorbidity which compromising the survival within 6 month
- Unintentional low DEI <20 kcal kg_1 day_1
- HIV or HCV positive
- History of hormone dependent cancer
- Suspected or confirmed prostate cancer or breast carcinoma
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 |
|---|---|---|
| training on ergonomic bicycle | Other | treated group |
| Testosterone | Drug | treated group |
| Oral nutritional supplementation | Drug | control group, treated group |
| n3 polyunsaturated fatty acid | Drug | treated group |
Primary outcome
Change of physical endurance on bicycle
Time frame: At months 3 and 15 after inclusion
Physical endurance on bicycle at intermediate power between maximal power and ventilatory threshold power (Pmax+Pthreshold)/2
9 secondary outcomes
Transthyrin serum concentration evolution
Time frame: at day 1
Health-related quality of life assessment using SF-36 scale and KDQOL
Time frame: at day 1
Karnofsky score
Time frame: at ady 1
Maximal power on bicycle
Time frame: at day 1
Nutritional parameters
Time frame: at day 1
serum levels of albumin (g/L)
Time frame: at day 1
determination of urea (mmol/L)
Time frame: at day 1
determination of creatinine(µmol/L)
Time frame: at 1 year
Body composition
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Derived from this study: PubMed 32390133Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
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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.
Noël CANO principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing training on ergonomic bicycle, Testosterone and Oral nutritional supplementation in people with Chronic Kidney Failure, run by University Hospital, Clermont-Ferrand 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 11 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: status not confirmed, as of the sponsor's last update on 29 Jul 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of physical endurance on bicycle (time frame: At months 3 and 15 after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02418065, which also lists 1 linked publication.
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 29 Jul 2016.