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Sponsors and Collaborators: |
Pharmalink AB Archimedes Development Ltd |
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Information provided by: | Pharmalink AB |
ClinicalTrials.gov Identifier: | NCT00767221 |
The study will investigate the effect of PL-56 on albumin leakage and renal function (glomerular filtration rate) in patients with IgA nephropathy. It will also assess the safety of treatment with PL-56.
Condition | Intervention | Phase |
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IGA Nephropathy |
Drug: Budesonide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study |
Estimated Enrollment: | 20 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
The patient is his own control. Endpoint variables are measured before, during and after treatment.
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Drug: Budesonide
8 mg PL-56 once daily for six months
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Huddinge University Hospital | |
Stockholm, Sweden | |
Linköping University Hospital | |
Linköping, Sweden | |
Uppsala University Hospital | |
Uppsala, Sweden |
Principal Investigator: | Bengt Fellström, MD, PhD | Uppsala University Hospital, Dept. of Medicine |
Responsible Party: | Pharmalink AB ( Johan Häggblad ) |
Study ID Numbers: | U-03-003 |
Study First Received: | October 5, 2008 |
Last Updated: | October 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00767221 |
Health Authority: | Sweden: Medical Products Agency |
Glomerulonephritis Autoimmune Diseases Urologic Diseases Nephritis |
Budesonide Berger disease Glomerulonephritis, IGA Kidney Diseases |
Anti-Inflammatory Agents Respiratory System Agents Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Glucocorticoids |
Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |