Description:

ODM derived from http://clinicaltrials.gov/show/NCT00554502

Link:

http://clinicaltrials.gov/show/NCT00554502

Keywords:
Versions (4) ▾
  1. 12/10/13
  2. 4/15/14
  3. 4/15/14
  4. 9/20/21
Uploaded on:

September 20, 2021

DOI:
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License:
Creative Commons BY 4.0
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Eligibility DRKS00006521 NCT00554502 IGA Nephropathy

Details

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 18 Years to 70 Years
Male or female patients from 18-70 years with histologically proven primary IgAN with typical mesangioproliferative features. Diagnosis has to be made by a neuropathologist.
Proteinuria above 0.75 g/day within 12 weeks prior to or at the first visit in the run-in phase (month -6)and presence of at least one further risk factor for the development of end stage renal disease 1. arterial hypertension, defined as ambulatory blood pressure >140/90 mm Hg or the use of antihypertensive medication or 2. impaired renal function, defined as creatinine clearance or estimated GFR <90 ml/min.
Exclusion Criteria
Known allergy or intolerance to study medication (except in case of ACE-inhibitor, in which case a change to an angiotensin receptor blocker is possible).
Women who are pregnant or breastfeeding and women without sufficient contraception.
Any prior immunosuppressive therapy.
Variants of primary IgAN (e.g. rapidly progressive IgAN with crescents in >50% of glomeruli or minimal change GN with glomerular IgA deposits).
Significant liver dysfunction (more than three fold increased GPT compared to norm)
Contraindication for immunosuppressive therapy, like
acute or chronic infectious disease incl. hepatitis and HIV positive patients
Malignant Neoplasms
leukocytopenia, thrombocytopenia or known allergy against prednisolone, cyclophosphamide or azathioprine
active intestinal bleeding, active gastric or duodenal ulcer
Need of permanent immunosuppression, (e.g. transplanted patients, steroid-dependent inflammatory diseases)
Secondary IgAN or diseases associated with glomerular deposits of IgA.
Additional other chronic renal disease.
Creatinine clearance below 30 ml/min (mean of 3 measurements).
Alcohol or drug abuse
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Participation in a parallel clinical trial or participation in another clinical trial within the last 3 months.
Subjects who are in any state of dependency to the sponsor or the investigators.
Employees of the sponsor or the investigators.
Subjects who have been committed to an institution by legal or regulatory order.
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