Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

Chronic Kidney Failure Clinical Trial

— AMERICANO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02418065
• Other study ID #: CHU-0231
• Status: Recruiting
• Phase: Phase 3
• First received: April 3, 2015
• Last updated: July 28, 2016
• Start date: December 2013
• Est. completion date: April 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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 Disease (CKD) patient.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Kidney Failure, Chronic
• Malnutrition
• Renal Insufficiency

Intervention

Other:
• training on ergonomic bicycle

Drug:
• Testosterone

• Oral nutritional supplementation

• n3 polyunsaturated fatty acid

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Human Nutrition Research Center Rhône-Alpes, NUTRICIA, Société Francophone Nutrition Clinique et Métabolisme

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of physical endurance on bicycle	Physical endurance on bicycle at intermediate power between maximal power and ventilatory threshold power (Pmax+Pthreshold)/2	At months 3 and 15 after inclusion	No
Secondary	Transthyrin serum concentration evolution	(Unit of Measure: g/L)	at day 1	No
Secondary	Health-related quality of life assessment using SF-36 scale and KDQOL		at day 1	No
Secondary	Karnofsky score		at ady 1	No
Secondary	Maximal power on bicycle	Unit of Measure: Watt	at day 1	No
Secondary	Nutritional parameters	weight (Kg)	at day 1	No
Secondary	serum levels of albumin (g/L)		at day 1	No
Secondary	determination of urea (mmol/L)		at day 1	No
Secondary	determination of creatinine(µmol/L)		at 1 year	No
Secondary	Body composition	(evaluated by bioimpedance)	at day 1	No