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ISRCTN
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ISRCTN64383094
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DOI
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10.1186/ISRCTN64383094
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Protein Metabolism in Chronic Kidney Disease
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Scientific title
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Effects of a low protein diet and of a keto/amino acid supplemented very low protein diet on muscle protein metabolism and myostatin in patients with chronic kidney disease
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Acronym
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PMCKD
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Serial number at source
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N/A
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Study hypothesis
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Our hypothesis is that the use of keto/amino acid supplements may partially or totally reverse the abnormal amino acid metabolism thus counteracting the uremia-related muscle cell loss and catabolic events.
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Lay summary
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Lay summary under review 2
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Ethics approval
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IRCCS Azienda Ospedaliera Universitaria “San Martino”- IST Istituto Nazionale per la Ricerca sul Cancro, 13/04/2012, ref: 7/2012
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Study design
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Non randomized prospective self controlled crossover trial
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Chronic kidney disease
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Participants - inclusion criteria
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1. Age 18-79 yrs, both males and females
2. Non-diabetic CKD [Stages 4-5, estimated glomerular filtration rate (eGFR) 12-25 ml/min]
3. Compliance to treatment
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Participants - exclusion criteria
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1. Evidence of congestive heart failure
2. Incapable of following study requirements to control diet
3. A recent myocardial infarction
4. Pregnancy
5. Unstable renal function
6. Recent (<3 months) infection history
7. Clinical evidence of gastrointestinal or liver diseases
8. Alcoholism
9. Drug abuse
10. Final diagnosis of malignancy
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Anticipated start date
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10/01/2013
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Anticipated end date
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06/06/2014
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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20
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Interventions
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Low protein diet or supplemented very low protein dieT (vLPD)
The research protocol is composed of two different studies:
Study A: to determine how skeletal muscle protein metabolism adapt to a low protein diet, forearm protein turnover will be evaluated in the same CKD patients assigned to a usual-protein diet (1.1 g/kg/day, 30-35 kcalday), followed by a low-protein diet (LPD) (0.8 g/kg, followed by 0.55 g/kg, 30-35 kcal/Kg/day). Each time period of study is 6 weeks, with total length of period of time during which patient will be followed up of 18-24 weeks. To determine the muscle responses to a supplemented vLPD (0,45 g/kg, supplemented with 0.1 g/kg Ketosteril, 30-35 kcal/Kg/day)
Study B: protein turnover (both whole body and muscle), muscle and plasma myostatin, muscle apoptosis, muscle proteolytic-related genes and intracellular insulin signaling, will be studied in a prospective cross-over trial with CKD patients serving as their own controls. Study B consists of four six-week consecutive periods: the enrollment period, the baseline (LPD) period, the treatment period (supplemented protein-restricted, vLPD) and the wash-out LPD period .
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Primary outcome measure(s)
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Chang in protein metabolism measured baseline and at the end of each six-week experimental period
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Secondary outcome measure(s)
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Change in serum / muscle myostatin measured baseline and at the end of each six-week experimental period
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Sources of funding
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Fresenius Kabi (Germany) - Ketosteril Award
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Trial website
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Publications
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Contact name
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Prof
Giacomo
Garibotto
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Address
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Viale Benedetto xv
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City/town
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Genoa
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Zip/Postcode
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16132
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Country
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Italy
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Email
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gari@unige.it
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Sponsor
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Fresenius Kabi Deutschland GmbH (Germany)
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Address
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Else-Kröner-Str.1
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City/town
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Bad Homburg
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Zip/Postcode
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61346
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Country
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Germany
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Email
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Anja.Markant@fresenius-kabi.com
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Sponsor website:
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http://www.fresenius-kabi.com/
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Date applied
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18/01/2013
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Last edited
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21/02/2013
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Date ISRCTN assigned
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21/02/2013
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