Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
Recruitment status was Not yet recruiting
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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 |
- 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 |
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| Contact: Baosong Gui, MD | 86-29-87679917 | guibsdoctor@sina.com.cn |
| 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 | |
| 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:
|
Prednisone Glomerulosclerosis, Focal Segmental Glomerulonephritis Nephritis Kidney Diseases Urologic Diseases Tacrolimus Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013