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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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

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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

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00569101

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

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

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