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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
Information provided by:
Seoul National University Hospital Identifier:
First received: December 4, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
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 Intervention Phase
Lupus Nephritis Drug: tacrolimus Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

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

Estimated Enrollment: 9
Study Start Date: September 2007
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00569101

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

Responsible Party: Suhnggwon Kim, Seoul National University Hospital Identifier: NCT00569101     History of Changes
Other Study ID Numbers: H-0706-049-211
Study First Received: December 4, 2007
Last Updated: December 4, 2007

Additional relevant MeSH terms:
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 23, 2017