Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
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ClinicalTrials.gov Identifier: NCT00956059 |
Recruitment Status : Unknown
Verified August 2009 by Health Science Center of Xi'an Jiaotong University.
Recruitment status was: Not yet recruiting
First Posted : August 11, 2009
Last Update Posted : August 11, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Focal Segmental Glomerulosclerosis | Drug: prednisone, FK506, MMF Drug: prednisone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis |
Study Start Date : | September 2009 |
Estimated Primary Completion Date : | December 2012 |
Estimated Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
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 |
- proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test [ Time Frame: 16~24 weeks ]

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Ages Eligible for Study: | 16 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956059
Contact: Baosong Gui, MD | 86-29-87679917 | guibsdoctor@sina.com.cn |
China, Shaanxi | |
The second affiliated hospital of medical college, Xi'an Jiaotong University | |
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 |
Responsible Party: | Gui Baosong, The Second Affiliated Hospital of Medical College,Xi'an JiaoTong University |
ClinicalTrials.gov Identifier: | NCT00956059 |
Other Study ID Numbers: |
CSX-090630-SAHXJTU DBDZL-1 DX-FSGS-1 YW-JS-XX-TKMS JL-5MG-50MG-500MG JG-YX-1 |
First Posted: | August 11, 2009 Key Record Dates |
Last Update Posted: | August 11, 2009 |
Last Verified: | August 2009 |
focal segmental glomerulosclerosis prednisone mycophenolate mofetil FK506 |
Glomerulosclerosis, Focal Segmental Glomerulonephritis Nephritis Kidney Diseases Urologic Diseases Prednisone Anti-Inflammatory Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |