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Kiovig as a treatment in CIDP


- candidate number2618
- NTR NumberNTR992
- ISRCTNISRCTN52121370
- Date ISRCTN created16-jul-2007
- date ISRCTN requested9-jul-2007
- Date Registered NTR5-jun-2007
- Secondary IDs 
- Public TitleKiovig as a treatment in CIDP
- Scientific TitleKiovig as a treatment in chronic inflammatory demyalinating polyneuropathy
- ACRONYMKIC study
- hypothesisIs Kiovig as effective as Gammagard in the treatment of CIDP symptoms
- Healt Condition(s) or Problem(s) studiedChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIPD), Immunoglobulin, Polyneuropathy
- Inclusion criteria1. Minimum age 18 years; 2. Improvement of muscle function after start Gammagard; 3. Active illness; 4. Ongoing intermittent treatment with a stable Gammagard dose; 5. Clinical and EMG findings compatible with CIDP
- Exclusion criteria1. IgA deficiency or allergic reactions to IVIg; 2. Hereditary neuropathy or severe concomittant illness; 3. MMn. atypical CIDP.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jul-2007
- planned closingdate1-jan-2008
- Target number of participants25
- InterventionsThe investigational product is Kiovig a brand of immunoglobulin. Kiovig will be compared to Gammagard (another brand of immunoglobulin). The first phase is a randomised dubbel-blind phase, where patients receive 1 infuse Gammagard, followed by 4 blind gifts (Gammagard or Kiovig) The second phase ia an open-label phase where all patients recieve 5 gifts Kiovig.
- Primary outcome1. The efficacy. The ODSS will be used as the primary outcome scale. A change of more than one point will be considered as improvement or worsening. 2. The vigorimeter and MRC sumscore will be used as secondary outcome scales.
- Secondary outcome1. The secondary objective will be to record the occurence of side-effects; 2. The preferences of patients regarding the medication.
- Timepoints
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES K. Kuitwaard
- CONTACT for SCIENTIFIC QUERIES P.A. Doorn, van
- Sponsor/Initiator Erasmus Medical Center, Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
Baxter
- Publications
- Brief summaryIn practise CIDP patients are treated with different brands of immunoglobulins that are considered to hace comparable efficacy, although this has not been formally investigated. Kiovig is a registered immunoglobulin which is easy to administer and can be infused faster. the first fase is a randomised double blind where patients receive either Kiovig or Gammagard. Neurological examination, muscle grip strenght and questionnaires are used to show if kiovig is as effective as Gammagard. the second fase is an open label fase where all the patients receive Kiovig
- Main changes (audit trail)
- RECORD5-jun-2007 - 16-jul-2007


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