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Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO) (AMERICANO)

Primary Purpose

Chronic Kidney Failure

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

training on ergonomic bicycle

Testosterone

Oral nutritional supplementation

n3 polyunsaturated fatty acid

About this trial

This is an interventional prevention trial for Chronic Kidney Failure focused on measuring Physical exercises, Oral nutritional supplementation, Multimodal, Hemodialysis, Protein-Energy Wasting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Sites / Locations

CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

treated group

control group

Arm Description

testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle

oral nutritional supplementation

Outcomes

Primary Outcome Measures

Change of physical endurance on bicycle

Physical endurance on bicycle at intermediate power between maximal power and ventilatory threshold power (Pmax+Pthreshold)/2

Secondary Outcome Measures

Transthyrin serum concentration evolution

(Unit of Measure: g/L)

Health-related quality of life assessment using SF-36 scale and KDQOL

Karnofsky score

Maximal power on bicycle

Unit of Measure: Watt

Nutritional parameters

weight (Kg)

serum levels of albumin (g/L)

determination of urea (mmol/L)

determination of creatinine(µmol/L)

Body composition

(evaluated by bioimpedance)

Full Information

NCT ID

NCT02418065

First Posted

April 3, 2015

Last Updated

July 28, 2016

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Human Nutrition Research Center Rhône-Alpes, Société Francophone Nutrition Clinique et Métabolisme, Nutricia, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02418065

Brief Title

Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

Acronym

AMERICANO

Official Title

Multimodal Therapeutic Approach by Exercise, Oral Nutritional Supplementation, Omega 3 and Androgen in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Human Nutrition Research Center Rhône-Alpes, Société Francophone Nutrition Clinique et Métabolisme, Nutricia, Inc.

4. Oversight

5. Study Description

Brief 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 Disease (CKD) patient.

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Failure

Keywords

Physical exercises, Oral nutritional supplementation, Multimodal, Hemodialysis, Protein-Energy Wasting

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treated group

Arm Type

Experimental

Arm Description

testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle

Arm Title

control group

Arm Type

Other

Arm Description

oral nutritional supplementation

Intervention Type

Other

Intervention Name(s)

training on ergonomic bicycle

Intervention Type

Drug

Intervention Name(s)

Testosterone

Intervention Type

Drug

Intervention Name(s)

Oral nutritional supplementation

Intervention Type

Drug

Intervention Name(s)

n3 polyunsaturated fatty acid

Primary Outcome Measure Information:

Title

Change of physical endurance on bicycle

Description

Physical endurance on bicycle at intermediate power between maximal power and ventilatory threshold power (Pmax+Pthreshold)/2

Time Frame

At months 3 and 15 after inclusion

Secondary Outcome Measure Information:

Title

Transthyrin serum concentration evolution

Description

(Unit of Measure: g/L)

Time Frame

at day 1

Title

Health-related quality of life assessment using SF-36 scale and KDQOL

Time Frame

at day 1

Title

Karnofsky score

Time Frame

at ady 1

Title

Maximal power on bicycle

Description

Unit of Measure: Watt

Time Frame

at day 1

Title

Nutritional parameters

Description

weight (Kg)

Time Frame

at day 1

Title

serum levels of albumin (g/L)

Time Frame

at day 1

Title

determination of urea (mmol/L)

Time Frame

at day 1

Title

determination of creatinine(µmol/L)

Time Frame

at 1 year

Title

Body composition

Description

(evaluated by bioimpedance)

Time Frame

at day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noël CANO

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

First Name & Middle Initial & Last Name & Degree

Dorothée BAZIN KARA

First Name & Middle Initial & Last Name & Degree

Didier DUCLOUX

First Name & Middle Initial & Last Name & Degree

Anne-Elizabeth HENG

First Name & Middle Initial & Last Name & Degree

Fitsum GUEBREEGZIABHE

First Name & Middle Initial & Last Name & Degree

Denis FOUQUE

First Name & Middle Initial & Last Name & Degree

Christophe MARIAT

First Name & Middle Initial & Last Name & Degree

Atman HADDJELMRABET

First Name & Middle Initial & Last Name & Degree

Didier AGUILERA

First Name & Middle Initial & Last Name & Degree

Eric LARUELLE

First Name & Middle Initial & Last Name & Degree

Charles CHAZOT

First Name & Middle Initial & Last Name & Degree

Abdallah GUERRAOUI

First Name & Middle Initial & Last Name & Degree

Myriam ISNARD

First Name & Middle Initial & Last Name & Degree

Prisca MUTINELLI

First Name & Middle Initial & Last Name & Degree

Hélène DE PRENEUF

First Name & Middle Initial & Last Name & Degree

François MAURICE

First Name & Middle Initial & Last Name & Degree

Pedro PALACIN

First Name & Middle Initial & Last Name & Degree

Daniel TETA

First Name & Middle Initial & Last Name & Degree

Marie ESSIG

12. IPD Sharing Statement

Citations:

PubMed Identifier

32390133

Citation

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.

Results Reference

derived

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Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

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