Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome - Full Text View

Sponsored by:	Peking University
Information provided by:	Peking University
ClinicalTrials.gov Identifier:	NCT00362531

Purpose

Idiopathic membranous nephropathy (IMN) is one of the most common forms of nephrotic syndrome (NS) in adults and is usually treated by corticosteroids in combination with cytotoxic drugs especially cyclophosphamide or cyclosporine. Tacrolimus, a new immunosuppressive agent, was proved to be effective in treating refractory NS.

Whether it is effective in IMN has not been reported. We therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients with idiopathic membranous nephropathy and nephrotic syndrome.

Condition	Intervention	Phase
Idiopathic Membranous Nephropathy Nephrotic Syndrome	Drug: tacrolimus combined with prednisone	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome

Resource links provided by NLM:

Drug Information available for: Prednisone Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Further study details as provided by Peking University:

Primary Outcome Measures:

complete remission of renal disease at 12 months

Secondary Outcome Measures:

partial remission at 12 months and adverse events

Study Start Date:	November 2004
Estimated Study Completion Date:	January 2007

Detailed Description:

Idiopathic membranous nephropathy (IMN) is one of the most common forms of nephrotic syndrome (NS) in adults and is usually treated by corticosteroids in combination with cytotoxic drugs especially cyclophosphamide or cyclosporine. However, the effect was not satisfying and the side-effects of the above immunosuppressive agents were often a worrying problem. Tacrolimus, a new immunosuppressive agent, was proved to be effective in treating refractory NS especially FSGS. Whether it is effective in IMN has not been reported. We therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients with idiopathic membranous nephropathy and nephrotic syndrome.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients were diagnosed as idiopathic membranous nephropathy according to renal histology, with nephrotic syndrome, serum creatinine less than 2.5mg/dL, 18~70 years old, signed the informed consent and willing to be followed up according to the protocol.

Exclusion Criteria:

Patients who had received immunosuppressive therapy within the previous 3 months, complicated other severe renal diseases, serum creatinine higher than 2.5mg/dL, severe infection, diabetes mellitus, liver disease, pregnancy, lactating, and anticipated poor compliance with the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362531

Sponsors and Collaborators

Peking University

Investigators

Principal Investigator:	Haiyan WANG, MD	Renal Division, Peking University First Hospital
Principal Investigator:	Jianghua Chen, MD	Department of Nephrology, First Hospital of Zhejiang University
Principal Investigator:	Xuewang Li, MD	Department of Nephrology, Peking Union Medical College Hospital
Principal Investigator:	Fuming Lu, MD	Department of Nephrology, Huashan Hospital, Fudan University
Principal Investigator:	Feifei Xu, MD	Department of Nephrology, First Hospital of Wenzhou Medical College
Principal Investigator:	Jiaqi Qian, MD	Department of Nephrology, Renji Hospital of Shanghai
Principal Investigator:	Fanfan Hou, MD	Department of Nephrology, Nanfang Hospital, First Military Medical University

More Information

No publications provided

Study ID Numbers:	PRGNSCN01-0, NCT00268567
Study First Received:	August 9, 2006
Last Updated:	August 9, 2006
ClinicalTrials.gov Identifier:	NCT00362531 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Glomerulonephritis
Autoimmune Diseases
Immunologic Factors
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Glomerulonephritis, Membranous
Tacrolimus

Membranous Nephropathy, Idiopathic
Immunosuppressive Agents
Glucocorticoids
Hormones
Nephrosis
Urologic Diseases
Nephritis
Kidney Diseases
Nephrotic Syndrome

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Glomerulonephritis
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Tacrolimus
Hormones
Nephrosis
Pathologic Processes
Urologic Diseases
Syndrome

Therapeutic Uses
Kidney Diseases
Disease
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents, Hormonal
Glomerulonephritis, Membranous
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Nephritis
Nephrotic Syndrome

ClinicalTrials.gov processed this record on September 02, 2009