Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT01362569
Eligibility Criteria:
Inclusion Criteria:
Age between 18-80 years, informed consent Groups 1a, 1b, 2a, 2b, 3a, 3b Patients with chronic kidney disease as defined previously \[65\] either
1a) with an eGFR between 30 and 45 (KDIGO 3B)
1. b) with an eGFR between 15 and 30 (KDIGO 4)
2. a) undergoing hemodialysis for ESRD
2b) undergoing hemodiafiltration for ESRD
3a) undergoing peritoneal dialysis for ESRD without signs of infection
3b) undergoing peritoneal dialysis for ESRD with peritonitis ≥2 out of the 4 criteria (\>100 leucocytes/50%neutrophils, cloudy peritoneal dialysate, typical clinical presentation with fever and abdominal pain, positive culture from the peritoneal dialysate)
Group 4 Patients with acute kidney injury (AKIN 3 \[66\] defined as an increase in serum creatinine to 300% (3-fold) from baseline or serum creatinine 4.0 mg/dl with an acute rise of at least 0.5mg/dl or urine output of \< 0.3ml/kg/h 24h or anuria 12h) Initiation of acute renal replacement therapy
Group 5 Stable patients after kidney transplantation with either an eGFR \> 45, between 30 and 45 or \< 30
Group 6: Healthy controls
Exclusion Criteria:
* Malignancy, pregnancy,chronic inflammatory bowel disease, celiac disease, active alcohol abuse, any severe organ dysfunction unrelated to renal dysfunction Groups 1a, 1b, 2a, 2b, 3 Organ transplantation Clinical evidence of active infection (except for group 3b) Treatment with antibiotics within the last 2 weeks (except for group 3b)
Group 4 Preexisting ESRD
Group 5 Clinical evidence of active infection Treatment with antibiotics within the last 2 weeks
Group 6:
Any evidence of acute or chronic disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01362569
Study Brief:
Protocol Section:
NCT01362569