Idiopathic Membranous NephropathyNCT00302523
Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy
A study testing Tacrolimus in people with Idiopathic Membranous Nephropathy, run by Nanjing University School of Medicine at 2 sites in China.
Trial summary
The purpose of this study is: To explore the potential role of tacrolimus in the treatment of membranous nephropathy. To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus cyclophosphamide. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Membranous Nephropathy
- What is being tested?
- Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2006to Dec 2009
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Biopsy-proven idiopathic membranous nephropathy
- Nephrotic syndrome with proteinuria ( > 4 g/day) and serum albumin < 30 g/dl
- Age 18-60 years with informed consent
Who cannot join
- Patient with abnormal liver function tests
- Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
- Active/serious infection
- Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
- Patient who is diabetic
- Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
Trial locations and contacts
2 sites in 1 country.
China2 sites
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, 210002
About this study
Official title: Tacrolimus Treatment of Patients With Idiopathic
The purpose of this study is:
- To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
- To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus cyclophosphamide.
Read the detailed description
Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a new calcineurin immunosuppressive drug, tacrolimus (FK506), in reducing the amount of protein in the urine in patients with membranous nephropathy. Forty patients with biopsy-proven membranous nephropathy will be recruited. Candidates must have completed at least six month of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy. They will be treated with oral tacrolimus for 6 months, followed by 6 months of maintenance. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day. This study will explore the potential role of tacrolimus in the treatment of membranous nephropathy, which is usually resistant to conventional therapy.
- Conditions
- Idiopathic Membranous Nephropathy
- Being tested
- Tacrolimus
- Keywords
- Idiopathic Membranous Nephropathy, Treatment, Tacrolimus, Cyclophosphamide
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Tacrolimus,Prograf
FK506,0.1mg/kg/d
| Study group | Role | What they receive |
|---|---|---|
| FK506 | Active comparator | Not described Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
Measured: 18 months
Secondary outcomes (1)
To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2008
- Study completionDec 2009
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 Idiopathic Membranous NephropathyStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-Hong Liu, M.D., Nanjing University School of Medicine
- Investigators
- Zhi-hong Liu, M.D., Study director, Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302523
- Sponsor's protocol ID
- NJCT-0603
- Status last verified
- Feb 2012
- First submitted
- 13 Mar 2006
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
PubMed 34778952
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus Treatment of Patients With Idiopathic
- ClinicalTrials.gov ID
- NCT00302523
- Acronym / sponsor ID
- NJCT-0603
- Conditions
- Idiopathic Membranous Nephropathy
- Keywords
- Idiopathic Membranous Nephropathy, Treatment, Tacrolimus, Cyclophosphamide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Mar 2006 (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 purpose of this study is:
- To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
- To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus cyclophosphamide.
Detailed description
Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a new calcineurin immunosuppressive drug, tacrolimus (FK506), in reducing the amount of protein in the urine in patients with membranous nephropathy. Forty patients with biopsy-proven membranous nephropathy will be recruited. Candidates must have completed at least six month of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy. They will be treated with oral tacrolimus for 6 months, followed by 6 months of maintenance. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day. This study will explore the potential role of tacrolimus in the treatment of membranous nephropathy, which is usually resistant to conventional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FK506 | Active comparator | Drug: Tacrolimus |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Biopsy-proven idiopathic membranous nephropathy
- Nephrotic syndrome with proteinuria ( > 4 g/day) and serum albumin < 30 g/dl
- Age 18-60 years with informed consent
Key exclusion criteria (6 listed)
- Patient with abnormal liver function tests
- Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
- Active/serious infection
- Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
- Patient who is diabetic
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 |
|---|---|---|
| TacrolimusAlso: Tacrolimus,PrografFK506,0.1mg/kg/d | Drug | FK506 |
Primary outcome
To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
Time frame: 18 months
1 secondary outcome
To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
- Derived from this study: PubMed 34778952von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
Related trials for Idiopathic Membranous Nephropathy
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
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
RecruitingPhase 2/3
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
Primary Membranous Nephropathy
RecruitingPhase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
Nephrotic Syndrome, Proteinuria
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
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.
Zhi-hong Liu, M.D. study director
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tacrolimus in people with Idiopathic Membranous Nephropathy, run by Nanjing University School of Medicine at 2 sites 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 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: finished, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To explore the potential role of tacrolimus in the treatment of membranous nephropathy. (time frame: 18 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 NCT00302523, 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 3 Feb 2012.