End Stage Renal Disease (ESRD), and haemodialysis Urological and Genital Diseases Renal Disease
Conditions
Interventions
Essential amino acid supplementation/placebo treatment in haemodialysis patient for six months or until a primary end-point is reached.
Sponsors
Recip AB (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients on maintenance haemodialysis for at least four months at high risk of hospitalisation. This is defined as: a. no more than two weeks post discharge from an acute hospitalisation and a serum albumin below 4.0 g/dl b. a serum albumin below 3.8 g/dl
Exclusion criteria
Exclusion criteria: 1. Patients who have difficulties in taking pills, due to problems swallowing or intractable vomiting 2. Patients who have a short time life expectancy or are awaiting non-cadaveric kidney transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was comparing the time of the composite primary outcome of : 1. Hospitalisation, other than for uncomplicated dialysis access procedure 2. Prolonged Emergency Room (ER) visit (more than 16 hours) 3. Out of hospital death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy analyses, for the following outcomes comparing the change in the given parameter from baseline to the last available study measurement: 1. Change in subjective global assessment 2. Change in grip strength 3. Change in quality of life measures (using Short Form 12 instrument) 4. Change in lowest post dialysis weight | — |
Countries
United States of America
Outcome results
None listed