FSGSFSGSNCT01451489

The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis

A study testing FK506 and Cyclophosphamide in people with FSGS, run by Nanjing University School of Medicine at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is a prospective,multicentre study to compare the efficacy, safety, tolerability and relapse of FK506 versus CTX in the treatment of severe Focal Segmental Glomerulosclerosis (FSGS). Read more about this study

Who is it for?: Ages 14 to 65 years
Conditions the study is for: FSGS
What is being tested?: FK506 and Cyclophosphamide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteChina
Study dates: 13 Oct 2011to 29 Oct 2016
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 14 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

patients with a diagnosis of FSGS.
Patients with a proteinuria ≥ 3.5g/24h,and blood albumin <30g/L,and Scr< 2.3 mg/dl and eGFR>30ml/min per 1.73m2.
Patients who signed written informed consent form (patients less than 18 years old with their parents/legal representative's signatures), and have given their consent to follow all study procedures and follow-up.

Who cannot join

Patients who have received treatment of FK506 in latest 2 month or the cumulative dose CTX≥6 g.
Patients who are known to be allergic to a macrolide.
Patients who have active hepatitis.
Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit .
Patients with blood leukocyte < 3000/ul.
Patients with kidney disease family history
Patients with 2 type diabetes.
Patients with obesity whose BMI>28kg/m2.

Trial locations and contacts

1 site in 1 country.

China1 site

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002

Other trials in China

About this study

Official title: A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis

This is a prospective,multicentre study to compare the efficacy, safety, tolerability and relapse of FK506 versus CTX in the treatment of severe Focal Segmental Glomerulosclerosis (FSGS).

Read the detailed description

Using the response rate and completely response time to compare the efficacy of FK506 versus CTX therapy for the severe FSGS patients.
To compare the safety and tolerability of FK506 versus CTX for the severe FSGS patients.

Conditions: FSGS
Being tested: FK506, Cyclophosphamide
Keywords: FSGS, FK506, CTX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FK506Drug
Also called Tacrolimus,Prograf
FK506:0.05-0.1mg/kg/d
CyclophosphamideDrug
Also called CTX
CTX 750mg/m2 per month in the induction phase,then 750mg/m2 every 2 month for 3 times,then 750mg/m2 every 3 months.

Study groups in NCT01451489
Study group	Role	What they receive
Cyclophosphamide	Active comparator	CTX Receives: Drug: Cyclophosphamide
FK506	Experimental	0.05-0.1mg/kg/d;adjust the dose according the serum concentration(aim 5-10ng/ml),maximum dose 6mg/day;divided in twice, interval 12 hours. Receives: Drug: FK506

What is being measured

The primary outcome is the main question the study is designed to answer.

the rates of the complete remission during the induction phase
Measured: 6 months

Secondary outcomes (1)

the total remission rates
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 201129 Oct 2016

First posted13 Oct 2011 (estimated)
Study start13 Oct 2011
Primary completion23 Mar 2016
Study completion29 Oct 2016

Why it stopped: The recruitment of subject is very difficult

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 FSGSStudies 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: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01451489
Sponsor's protocol ID: NJCT-1101
Acronym: FSGS
Status last verified: Mar 2017
First submitted: 5 Aug 2011
Last updated: 27 Mar 2017
Results posted: No
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Not yet recruitingPhase 2
A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
Primary Membranous Nephropathy, Minimal Change Disease

All FSGS trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis
ClinicalTrials.gov ID: NCT01451489
Acronym / sponsor ID: FSGS / NJCT-1101
Conditions: FSGS
Keywords: FSGS, FK506, CTX
Study type: Interventional
Recruitment status: TerminatedReason stopped: The recruitment of subject is very difficult
Enrolment: 70 participants (actual)
Lead sponsor: Nanjing University School of MedicineUniversity, hospital or other
Study start: 13 Oct 2011 (actual)
Primary completion: 23 Mar 2016 (actual)
Study completion: 29 Oct 2016 (actual)
First posted: 13 Oct 2011 (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.

This is a prospective,multicentre study to compare the efficacy, safety, tolerability and relapse of FK506 versus CTX in the treatment of severe Focal Segmental Glomerulosclerosis (FSGS).

Detailed description

Using the response rate and completely response time to compare the efficacy of FK506 versus CTX therapy for the severe FSGS patients.
To compare the safety and tolerability of FK506 versus CTX for the severe FSGS patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cyclophosphamide	Active comparator	Drug: CyclophosphamideCTX
FK506	Experimental	Drug: FK5060.05-0.1mg/kg/d;adjust the dose according the serum concentration(aim 5-10ng/ml),maximum dose 6mg/day;divided in twice, interval 12 hours.

Who may qualify

Ages: 14 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

patients with a diagnosis of FSGS.
Patients with a proteinuria ≥ 3.5g/24h,and blood albumin <30g/L,and Scr< 2.3 mg/dl and eGFR>30ml/min per 1.73m2.
Patients who signed written informed consent form (patients less than 18 years old with their parents/legal representative's signatures), and have given their consent to follow all study procedures and follow-up.

Key exclusion criteria (8 listed)

Patients who have received treatment of FK506 in latest 2 month or the cumulative dose CTX≥6 g.
Patients who are known to be allergic to a macrolide.
Patients who have active hepatitis.
Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit .
Patients with blood leukocyte < 3000/ul.

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
FK506Also: Tacrolimus,PrografFK506:0.05-0.1mg/kg/d	Drug	FK506
CyclophosphamideAlso: CTXCTX 750mg/m2 per month in the induction phase,then 750mg/m2 every 2 month for 3 times,then 750mg/m2 every 3 months.	Drug	Cyclophosphamide

Primary outcome

the rates of the complete remission during the induction phase
Time frame: 6 months

1 secondary outcome

the total remission rates
Time frame: 18 months

Results and safety

The study was stopped early (reason given: The recruitment of subject is very difficult). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
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.

Related trials for FSGS

RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Not yet recruitingPhase 2
A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
Primary Membranous Nephropathy, Minimal Change Disease

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.

Zhihong Liu, MD study director

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FK506 and Cyclophosphamide in people with FSGS, run by Nanjing University School of Medicine 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 27 Mar 2017. 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?

The study was stopped early (reason given: The recruitment of subject is very difficult). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the rates of the complete remission during the induction phase (time frame: 6 months). 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 NCT01451489, 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 27 Mar 2017.