Trial document



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  DRKS00015460

Trial Description

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Title

Selective depletion of C-reactive protein by therapeutic apheresis (CRP apheresis) in Crohn's disease and ulcerative colitis

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Trial Acronym

CAMCRO1

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URL of the Trial

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Brief Summary in Lay Language

CAMCRO1 is a clinical trial to evaluate the safety and efficacy of C-reactive protein (CRP) reduction by therapeutic apheresis (CRP apheresis) in patients with Crohn's disease and ulcerative colitis.
The term therapeutic apheresis generally refers to medical procedures whose therapeutic effect is based on the elimination of components of the blood to which a pathogenic function is attributed in the context of disease processes.
Elimination takes place in adsorbers outside the body in an extracorporeal circuit. To remove the pathogenic substances, blood plasma is separated from the circulation and passed through an adsorber. The purified blood plasma is then rejoined with the solid blood components and returned to the patient.
The PentraSorb® CRP adsorber used for CRP apheresis is CE certified. It is used for the selective depletion of the CRP from human cells.
As a cause for the damaging effect of the CRP, it is assumed that CRP as an inflammatory mediator favours the destruction of intestinal tissue (in combination with complement) and negatively influences the regeneration of traumatised tissue.
The CAMCRO1 study will investigate to what extent the tissue damage of the intestine can be reduced by depletion of the CRP in a relapse in Crohn's disease and ulcerative colitis.
A possible protective effect of CRP apheresis with regard to damage to intestinal tissue is to be determined from the course of the disease (Crohn's disease activity index (CDAI) / Mayo score and Limberg score), by steroid sparing and by determining the calprotectin concentration in stool, as well as by collecting the "Short Inflammatory Bowel Disease Questionnaire".

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Brief Summary in Scientific Language

The CAMCRO1 study is investigating the efficacy and tolerability of C-reactive protein depletion by CRP apheresis in patients with Crohn's disease and ulcerative colitis.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00015460
  •   2018/08/31
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  •   no
  •   Approved
  •   EA4/070/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1219-6714 
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Health Condition or Problem studied

  •   K50 -  Crohn disease [regional enteritis]
  •   K51 -  Ulcerative colitis
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Interventions/Observational Groups

  •   Each study participant will initially receive 6 apheresis treatments, each lasting approximately 4-6 hours over a period of 3 weeks (twice a week).
    The following week is used to determine the target parameters (CRP, calprotectin, CDAI/Mayo score, Limberg score).
    With unchanged increased CRP values (> 10 mg/l) 3 further treatments are carried out (once a week).
    The total duration of study participation is 12 weeks (including follow-up)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The plasma CRP concentration is determined before and after each apheresis (maximum 9 treatments) plus 2 control measurements each in the 4th and 8th week of treatment and 12 weeks after the start of treatment

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Secondary Outcome

Safety of CRP apheresis in the treatment of chronic inflammatory bowel disease (incidence of adverse effects of CRP apheresis), calprotectin concentration in stool, Crohn's disease activity index (CDAI)/Mayo score, Limberg score and „Short Inflammatory Bowel Disease Questionnaire“.
The corresponding parameters are determined before the start of the apheresis treatments, as well as 4., 8. and 12. weeks after the start of treatment.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2020/01/03
  •   20
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Crohn's disease/ulcerative colitis with active but stable manifestations; Crohn's disease: CDAI 200 - 450 (Crohn's disease activity index); Ulcerative colitis: Mayo score 3-12; Crohn's disease manifestation: Colon and/or small intestine (endoscopic evidence); Ulcerative colitis manifestation: at least rectosigmoiditis; Stable therapy and medication within the previous 4 weeks

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Exclusion Criteria

Age < 18 ≥ 65 years, Acute infectious disease (body temperature (auricular, sublingual) > 38.0 °C), abscesses, blind fistulas, Known hypersensitivity to therapeutic apheresis, pregnancy or lactation, Participation in other interventional tests, Dialysis-liable renal failure

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Addresses

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    • Pentracor GmbH
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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    • Pentracor GmbH
    • Mr.  Dr.  Burghard  Thiesen 
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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    • Pentracor GmbH
    • Mr.  Dr.  Burghard  Thiesen 
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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Sources of Monetary or Material Support

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    • Pentracor GmbH
    • Neuendorfstr. 23 b/d
    • 16761  Hennigsdorf
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.