Focal Segmental GlomerulosclerosisNCT00956059
Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
A study testing prednisone, FK506, MMF and prednisone in people with Focal Segmental Glomerulosclerosis, run by Xi'an Jiaotong University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Focal Segmental Glomerulosclerosis
- What is being tested?
- prednisone, FK506, MMF and prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of medical college, Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
Baosong Gui, MD, 86-29-87679917, guibsdoctor@sina.com.cn
About this study
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.
Read the 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.
- Conditions
- Focal Segmental Glomerulosclerosis
- Being tested
- prednisone, FK506, MMF, prednisone
- Keywords
- focal segmental glomerulosclerosis, prednisone, mycophenolate mofetil, FK506
- Medical subject headings
- Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisone, FK506, MMFDrug
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
prednisoneDrug
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
| Study group | Role | What they receive |
|---|---|---|
| prednisone, MMF and FK506 | Experimental | Not described Receives: Drug: prednisone, FK506, MMF |
| prednisone | Active comparator | Not described Receives: Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test
Measured: 16~24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focal Segmental GlomerulosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Investigators
- Baosong Gui, MD, Study chair, The second affiliated hospital of Medical College, Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956059
- Sponsor's protocol ID
- CSX-090630-SAHXJTU
- Other IDs
- DBDZL-1, DX-FSGS-1, YW-JS-XX-TKMS, JL-5MG-50MG-500MG, JG-YX-1
- Status last verified
- Aug 2009
- First submitted
- 10 Aug 2009
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
PubMed 35224732
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
- ClinicalTrials.gov ID
- NCT00956059
- Acronym / sponsor ID
- CSX-090630-SAHXJTU
- Conditions
- Focal Segmental Glomerulosclerosis
- Keywords
- focal segmental glomerulosclerosis, prednisone, mycophenolate mofetil, FK506
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 11 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prednisone, MMF and FK506 | Experimental | Drug: prednisone, FK506, MMF |
| prednisone | Active comparator | Drug: prednisone |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prednisone, FK506, MMF1.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 | Drug | prednisone, MMF and FK506 |
| prednisoneIn 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 | Drug | prednisone |
Primary outcome
proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test
Time frame: 16~24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2009.
- Derived from this study: PubMed 35224732Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baosong Gui, MD study chair
The second affiliated hospital of Medical College, Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prednisone, FK506, MMF and prednisone in people with Focal Segmental Glomerulosclerosis, run by Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baosong Gui, MD (86-29-87679917, guibsdoctor@sina.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test (time frame: 16~24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00956059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2009.