A Phase-II, double-blind, randomized, placebo-controlled proof of concept study on the safety and early efficacy of Alkaline Phosphatase in sepsis patients with Renal Failure. - A phase-II db plb-ctrld RCT on Safety and early efficacy of AP in sepsis patients with renal failure

Phase 1

• Conditions: Sepsis with Renal Failure; MedDRA version: 9.1Level: LLTClassification code 10038435Term: Renal failure; MedDRA version: 9.1Level: LLTClassification code 10040050Term: Sepsis NOS

• Registration Number: EUCTR2007-003866-16-BE
• Lead Sponsor: AM-Pharma B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-16
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

•Patients =18 years and =80 years.
•Proven or suspected infection.
•Two out of four SIRS criteria of systemic inflammation, as follows:
•Core temperature =38° or =36° Celsius.
•Heart rate =90 beats/min (unless the patient has a medical condition known to increase heart rate or is receiving treatment that would prevent tachycardia).
•Respiratory rate =20 breaths/min, a PaCO2 =32mmHg or the use of mechanical ventilation for an acute respiratory process.
•White-cell count =12,000/mm3 or =4,000/mm3 or a differential count showing >10 percent immature neutrophils.
•Acute renal failure, defined as - rise in serum creatinine level to =150µmol/L within the previous 48 hours, in the absence of primary underlying renal disease OR - Minimally a stage 1 Kidney Injury according to AKIN criteria: Increase in serum creatinine =26.2 µmol/l (0.3mg/dl) or increase to =150% (=1.5 -fold) from baseline in the previous 48 hours in the absence of primary underlying renal disease and where baseline creatinine is less than 150umol/l OR - minimally a stage 1 Kidney injury according to AKIN Urine Output criteria: Urine Output of = 0.5mg/kg/h for =6 h and following adequate fluid resuscitation when applicable, in the absence of underlying primary renal disease and where baseline creatinine is less than 150umol/l
•Written informed consent obtained prior to any study intervention.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

••Pregnant women or nursing mothers and fecund females who are not on effective contraception (chemical: pill; or mechanical: IUD)
•Known HIV (sero-positive) patients
•Patients already on dialysis (RRT) at entry
•Patients receiving immunosuppressant therapy or on chronic high doses of steroids equivalent to prednisone 1mg/Kg/day
•Patients expected to have rapidly fatal disease within 24 hours
•Known confirmed gram-positive sepsis
•Known confirmed fungal sepsis
•Acute pancreatitis with no established source of infection
•Patients not expected to survive for 28 days due to other medical conditions such as end-stage neoplasm or other diseases
•Participation in another investigational study within 90 days prior to start of the study which might interfere with this study
•Any previous administration of active study medication.
•Known allergy for dairy (bovine) products including cow milk.
•Sepsis without renal failure as defined in the Entry Criteria.
•History of chronic renal failure or history of persistent creatinine level equal or greater than 150umol/L prior to entry for reasons other than the current sepsis condition.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified