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A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT00569101
Recruitment Status : Unknown
Verified December 2007 by Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 6, 2007
Last Update Posted : December 6, 2007
Sponsor:
Information provided by:
Seoul National University Hospital

Brief Summary:
The purpose of this protocol is to determine whether Tacrolimus and Prednisolone are effective and safe in the treatment of the cyclophosphamide-resistant, refractory diffuse proliferative lupus nephritis

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: tacrolimus Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
Study Start Date : September 2007
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: single
single arm study (tacrolimus trial group)
Drug: tacrolimus
during the first 2 months : tacrolimus 0.1 mg/kg + prednisolone 0.8 mg/kg p.o. ,then after : tacrolimus 0.1 mg ~0.02 mg/kg + prednisolone tapering



Primary Outcome Measures :
  1. Reducing proteinuria [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy-proven lupus nephritis WHO Class IV , IV+V
  • Previously treated by three times over of i.v. cyclophosphamide or 6 months more duration of immunosuppressive treatments (azathioprine, MMF, cyclophosphamide p.o.) for the lupus nephritis
  • spot urine Protein creatinine raio > 1.0
  • RBC > 5 /HPF on microscopic examination of urine

Exclusion Criteria:

  • previous treatment of cyclosporine A or tacrolimus
  • serum Creatinine lever : over 300 mmol/dl
  • allergy to the macrolide antibiotics
  • other systemic organ damage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569101


Locations
Korea, Republic of
SeoulNUH
Seoul, Chongno-gu, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Suhnggwon Kim, MD, PhD Korea : Seoul National University Hospital

Responsible Party: Suhnggwon Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00569101     History of Changes
Other Study ID Numbers: H-0706-049-211
20070217867
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: December 6, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action