Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

NCT02418065 | Unknown Phase 3

• 1 other identifier: CHU-0231
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Transthyrin serum concentration evolution

  at day 1

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

  at day 1

• Karnofsky score

  at ady 1

• Maximal power on bicycle

  at day 1

• Nutritional parameters

  at day 1

Study Arms (2)

treated group

EXPERIMENTAL

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

Other: training on ergonomic bicycle; Drug: Testosterone; Drug: Oral nutritional supplementation; Drug: n3 polyunsaturated fatty acid

control group

OTHER

oral nutritional supplementation

Drug: Oral nutritional supplementation

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Human Nutrition Research Center Rhône-Alpes: collaborator
• Société Francophone Nutrition Clinique et Métabolisme: collaborator
• Nutricia, Inc.: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 32390133 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity

Interventions

Testosterone; Dietary Supplements; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Noël CANO

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 16, 2015
• Study Start: December 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

FR (1)