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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 because the information has not been verified recently.
Verified December 2007 by Seoul National University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00569101
First received: December 4, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Reducing proteinuria [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Suhnggwon Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00569101     History of Changes
Other Study ID Numbers: H-0706-049-211, 20070217867
Study First Received: December 4, 2007
Last Updated: December 4, 2007
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013