Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006497

Trial Description

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Title

A Randomized Controlled, Single-blind, Proof-of-concept-study to Investigate the Protective Effects of Early Treatment With C.E.R.A. in Patients With Chronic Kidney Disease on Renal Disease Progression (PRIMAVERA-Study)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This randomized, single-blind, proof-of-concept study will investigate the prote ctive
effects of early treatment with Mircera (methoxy polyethylene glycol-epoet in beta) in
patients with chronic kidney disease on renal disease progression. P atients will be
randomized to receive 30 µg Mircera as subcutaneous injection on ce monthly or matching
placebo. Depending on change of hemoglobin values, the do se of Mircera can be adjusted to
50 µg or 75 µg once monthly. The anticipated ti me on study treatment is 24 months.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006497
  •   2015/01/21
  •   2010/08/25
  •   no
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Secondary IDs

  •   2009-015114-22 
  •   NCT01194154  (ClinicalTrials.gov)
  •   ML22916  (Hoffmann-La Roche)
  •   2009-015114-22 
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Health Condition or Problem studied

  •   Kidney Disease, Chronic
  •   N18 -  Chronic kidney disease
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Interventions/Observational Groups

  •   Drug: Mircera
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- To investigate the protective effects of early treatment with Mircera on the decline of renal function; time frame: 24 months

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Secondary Outcome

- Urinary protein creatinine ratio; time frame: 24 months
- Safety: Incidence of adverse events; time frame: 24 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2010/09/30
  •   241
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Adult patients, 18 years of age

- For diabetic patients: Type 2 diabetes mellitus with HbA1c >7% or anti-diabetic
treatment

- For renal allograft recipients: Status between 6 months and 10 years post
transplantation

- Chronic kidney disease stage III

- Urinary albumine-to-creatinine ratio between >100 and <1000 mg/g creatinine

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Exclusion Criteria

- Hb-level <1 or 14 g/dL

- Initiation of angiotensin converting enzyme inhibitor, angiotensin 2 receptor blocker
or aliskiren treatment less than 3 months before enrolment

- Iron deficiency

- HbA1c >9%

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Hoffmann-La Roche
    • Clinical Trials 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.