Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis

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 August 2009 by Health Science Center of Xi’an Jiaotong University.
Recruitment status was: Not yet recruiting

Sponsor:

Information provided by:

Health Science Center of Xi’an Jiaotong University

ClinicalTrials.gov Identifier:

NCT00956059

First received: August 10, 2009

Last updated: NA

Last verified: August 2009

History: No changes posted

Purpose

The aim of this clinical trial is to determine the effect and security of low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis.

Condition	Intervention
Focal Segmental Glomerulosclerosis	Drug: prednisone, FK506, MMF Drug: prednisone


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis

Resource links provided by NLM:

MedlinePlus related topics: Steroids

Drug Information available for: Prednisone Tacrolimus

Genetic and Rare Diseases Information Center resources: Focal Segmental Glomerulosclerosis Glomerulonephritis

U.S. FDA Resources

Further study details as provided by Health Science Center of Xi’an Jiaotong University:

Primary Outcome Measures:

proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test [ Time Frame: 16~24 weeks ]


Estimated Enrollment:	40
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: prednisone, MMF and FK506	Drug: prednisone, FK506, MMF 1.in the initial 3 months，prednisone dosage is 30mg per day；in the following 4~6 months，prednisone dose decreased to 20mg per day，then tapered gradually to 10mg per day；2.the initial dosage of FK506 is 0.2mg/kg/d, twice per day，the maintenance dosage is adjust to the serum concentration of FK506 (is maintained at the level of 6~10μg/L)；3. the initial dosage of MMF is 1.0g, twice per day，then reduce to 0.75 g, twice per day after 3 months
Active Comparator: prednisone	Drug: prednisone In the initial 16~24 weeks，prednisone is given at full dose of 1mg/kg/d，then prednisone is tapered gradually，the whole course of treatment is 52 weeks

Arms

Assigned Interventions

Experimental: prednisone, MMF and FK506

Drug: prednisone, FK506, MMF

1.in the initial 3 months，prednisone dosage is 30mg per day；in the following 4~6 months，prednisone dose decreased to 20mg per day，then tapered gradually to 10mg per day；2.the initial dosage of FK506 is 0.2mg/kg/d, twice per day，the maintenance dosage is adjust to the serum concentration of FK506 (is maintained at the level of 6~10μg/L)；3. the initial dosage of MMF is 1.0g, twice per day，then reduce to 0.75 g, twice per day after 3 months

Active Comparator: prednisone

Drug: prednisone

In the initial 16~24 weeks，prednisone is given at full dose of 1mg/kg/d，then prednisone is tapered gradually，the whole course of treatment is 52 weeks

Detailed Description:

Focal segmental glomerular sclerosis (FSGS) is characterized by heavy proteinuria and nephritic syndrome in clinic. The major pathological change is scarring of the glomerulus that is focal and segmental. The incidence of FSGS is increasing in recent years, but no unified protocol for FSGS treatment has been provided. Corticosteroid is the primary drug for FSGS treatment in clinic. However, corticosteroid treatment has a low response rate as 20% in clinic but some severe side-effects. The side-effects of long-term corticosteroid treatment urged researchers to find more reliable and secure methods for FSGS treatment. The new immunosuppressants shed light on FSGS treatment recently. The usage of immunosuppressants to FSGS treatment is in the preliminary stage and accounts for a few problems. The main problems include the uncertainty of curative effects, the lack of large-scale clinical trial, the side-effects of long-term application, and the high recurrence rate after withdraw. FSGS is immune-induced damage, which includes abnormality of many steps in humoral immunity and cellular immunity. According to it, we designed to inhibit the immune response at multi-targets with Prednisone Combined With MMF and FK506. Thus the dosage of these drugs can be decreased to a secure level for long-term treatment while the side-effects can be controlled well. Prednisone Combined With MMF and FK506 then can be used to FSGS treatment with effectiveness and security.

Eligibility


Ages Eligible for Study:	16 Years to 70 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Urinary protein≥1.0g/24h
Biopsy-proved FSGS
Age≥16years
Understanding of the content of this study，signing informed consent form
Adherence to drug taking and being able to be long-term followed up

Exclusion Criteria:

Sharp deterioration of renal function
Refractory hypertension
Secondary FSGS
Serious disease of liver，active stage of viral hepatitis，or AST、ALT≥2.5 times of baseline
Serious myelosuppression
Being unable to be long-term followed up

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956059

Contacts


Contact: Baosong Gui, MD	86-29-87679917	guibsdoctor@sina.com.cn

Locations


China, Shaanxi
The second affiliated hospital of medical college, Xi'an Jiaotong University	Not yet recruiting
Xi'an, Shaanxi, China, 710004
Contact: Baosong Gui, MD 86-29-87679917 guibsdoctor@sina.com.cn

Sponsors and Collaborators

Health Science Center of Xi’an Jiaotong University

Investigators


Study Chair:	Baosong Gui, MD	The second affiliated hospital of Medical College, Xi'an Jiaotong University

More Information


Responsible Party:	Gui Baosong, The Second Affiliated Hospital of Medical College,Xi'an JiaoTong University
ClinicalTrials.gov Identifier:	NCT00956059 History of Changes
Other Study ID Numbers:	CSX-090630-SAHXJTU DBDZL-1 DX-FSGS-1 YW-JS-XX-TKMS JL-5MG-50MG-500MG JG-YX-1
Study First Received:	August 10, 2009
Last Updated:	August 10, 2009

Keywords provided by Health Science Center of Xi’an Jiaotong University:


focal segmental glomerulosclerosis prednisone mycophenolate mofetil FK506

Additional relevant MeSH terms:


Glomerulosclerosis, Focal Segmental Glomerulonephritis Nephritis Kidney Diseases Urologic Diseases Prednisone Tacrolimus Anti-Inflammatory Agents Glucocorticoids Hormones	Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Calcineurin Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 22, 2017

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