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SepsisPhase 2NCT00511186

A Study in Sepsis Patients With Renal Failure

A Phase 2 study testing BIAP in people with Sepsis and Bacterial Infections and Mycoses, run by AM-Pharma at 9 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to investigate the safety and tolerability of AP in sepsis patients with renal failure and to investigate the effect of AP on inflammatory and clinical parameters in sepsis patients with renal failure. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Sepsis, Bacterial Infections and Mycoses
What is being tested?
BIAP
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
9 sitesin 2 countries
Study dates
May 2008to Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients between the age of 18 and 80 years.
  • Proven or suspected infection.
  • Two out of four SIRS criteria of systemic inflammation, existing for less than 24 hours after admission in the intensive care unit, as follows:
  • Core temperature higher then 38 degree Celsius or lower then 36 degree Celsius.
  • Heart rate above 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 above 20 breaths/min, a PaCO2 lower then 32mmHg or the use of mechanical ventilation for an acute respiratory process.
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  • White-cell count above 12,000/mm3 or below 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 creatinine criteria: Increase in serum creatinine ≥26.2µmol/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 150 µmol/L) OR
  • Minimally a stage 1 Kidney Injury according to AKIN Urine Output criteria: Urine Output of ≤ 0.5mg/kg/h for ≥6h and following adequate fluid resuscitation when applicable, in the absence of underlying primary renal disease and where baseline creatinine is less than 150µmol/L)
  • Written informed consent obtained prior to any study intervention.

Who cannot join

  • Pregnant women or nursing mothers and fecund females who are not on effective contraception (chemical: pill; or mechanical: IUD)
  • Patients already on dialysis (RTT) at entry
  • Known HIV (sero-positive) patients
  • 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
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  • 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".

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Netherlands5 sites

  • Jeroen Bosch Ziekenhuis lokatie GZG

    's-Hertogenbosch

  • VU University Medical Center

    Amsterdam

  • UMC Nijmegen University Medical Center St Radboud

    Nijmegen, Gelderland, 6500 HB

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen

  • Isala Clinics

    Zwolle, Overijssel, 8011 JW

Other trials in Netherlands

Belgium4 sites

  • University Medical Center Antwerp (UZA)

    Antwerp

  • Cliniques Universitaires Saint Luc-UCL

    Brussels

  • ULB Hopital Erasme

    Brussels

  • Universitair Ziekenhuis Brussel

    Brussels

Other trials in Belgium

About this study

Official title: A Phase-IIa, Double-blind, Randomized, Placebo-controlled Study on the Safety and Early Efficacy of Alkaline Phosphatase in Sepsis Patients With Renal Failure

The purpose of this study is to investigate the safety and tolerability of AP in sepsis patients with renal failure and to investigate the effect of AP on inflammatory and clinical parameters in sepsis patients with renal failure.

Read the detailed description

RATIONALE FOR THE STUDY

A previous clinical study conducted in centers in The Netherlands and Belgium have shown a substantial clinical benefit of AP treatment in patients with sepsis and associated acute renal failure (see Introduction above). The latter results require confirmation in a prospective study, as the current subject of this Protocol.

Choice of Drugs

The proposed study medication (AP) is identical to the study medication used in the previous clinical study in sepsis patients with single or multiple end-organ failure. Since there is no current proven treatment for these patients, the controls (as in previous studies) is placebo.

Choice of patient population

The aim is to enroll a maximum of 26 patients positive for sepsis with an APACHE score of ≥20 and ≤28 (determined within 24 hours of entry), and who will be analyzed on an intention to treat (ITT) basis.

Being tested
Placebo, BIAP
Keywords
Sepsis, Alkaline Phosphatase, inflammation, infection, renal failure
Medical subject headings
Sepsis, Bacterial Infections and Mycoses, Inflammation, Infections, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    placebo is administered intravenously over 48 hours. An initial loading dose of over 10-minutes is followed by continuous infusion over 48h.

  • BIAPDrug

    Also called AP

    AP is administered intravenously over 48 hours. An initial loading dose of 67.5U/Kg body weight over 10-minutes is followed by continuous infusion of 132.5U/Kg/24H administered over 48H

Study groups in NCT00511186
Study groupRoleWhat they receive
Bovine Intestinal APExperimentalBovine Intestinal Alkaline Phosphatase (BIAP) Intravenous administration of 10" bolus (67,5U/kg) and 48h continuous infusion (132,5U/kg)
Receives: Drug: BIAP
2Placebo comparatorPlacebo Intravenous administration of 10" bolus and 48h continuous infusion
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring.

    Measured: 28 Days

Secondary outcomes (3)

  1. To investigate the effect of AP on inflammatory parameters in sepsis patients with renal failure.

    Measured: 28 Days

  2. To investigate the effect of AP on clinical variables in sepsis patients with renal failure.

    Measured: 28 Days

  3. To investigate the effect of AP on renal function markers in sepsis patients with renal failure.

    Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2007 (estimated)
  2. Study startMay 2008
  3. Primary completionDec 2009
  4. Study completionDec 2009

Why it stopped: sufficient POC to switch development from bovine AP to recombinant AP

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00511186
Sponsor's protocol ID
AP REN 01-01
Status last verified
Mar 2012
First submitted
2 Aug 2007
Last updated
2 Apr 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Pickkers P, Heemskerk S, Schouten J, Laterre PF, Vincent JL, Beishuizen A, Jorens PG, Spapen H, Bulitta M, Peters WH, van der Hoeven JG. Alkaline phosphatase for treatment of sepsis-induced acute kidney injury: a prospective randomized double-blind placebo-controlled trial. Crit Care. 2012 Jan 23;16(1):R14. doi: 10.1186/cc11159.

    PubMed 22269279

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIAP in people with Sepsis and Bacterial Infections and Mycoses, run by AM-Pharma at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: sufficient POC to switch development from bovine AP to recombinant AP). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring. (time frame: 28 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00511186, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.

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A Study in Sepsis Patients With Renal Failure | AzTrials