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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Xi’an Jiaotong University College of Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Xi’an Jiaotong University College of Medicine
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
Endpoint Classification: Safety/Efficacy Study
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:


Further study details as provided by Xi’an Jiaotong University College of Medicine:

Primary Outcome Measures:
  • proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test [ Time Frame: 16~24 weeks ] [ Designated as safety issue: Yes ]

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

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
Genders Eligible for Study:   Both
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
Xi’an Jiaotong University College of Medicine
Investigators
Study Chair: Baosong Gui, MD The second affiliated hospital of Medical College, Xi'an Jiaotong University
  More Information

No publications provided

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
Health Authority: China: Ethics Committee

Keywords provided by Xi’an Jiaotong University College of Medicine:
focal segmental glomerulosclerosis
prednisone
mycophenolate mofetil
FK506

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Kidney Diseases
Nephritis
Urologic Diseases
Prednisone
Tacrolimus
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014