Lupus NephritisNCT01056237
Long-Term Study of Multi-target Therapy as Maintenance Treatment for Lupus Nephritis
A study testing Multi-target therapy and Azathioprine in people with Lupus Nephritis, run by Zhi-Hong Liu, M.D. at 1 site in China.
Trial summary
An multi-site, randomized, prospective study to compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Multi-target therapy and Azathioprine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- Feb 2010to Jun 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who signed written informed consent form
- SLE patient, aged between 18-65 years, female or male;
- Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy
- All patients had received induction therapy for 6 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
- Patients were recruited when received partial remission or complete remission after 6 months induction therapy.
- Complete remission: proteinuria <0.4 g/24h, negative urine sediment, serum albumin >35 g/L, elevated scr <0.3mg/dl, no extra-renal complications; Partial remission: proteinuria <1.0 g/24h, urine RBC <50X104/ml without casts, serum albumin > 30 g/L, elevated Scr <0.3mg/dl,no extra-renal complications.
Who cannot join
- Patients who didn't sign written informed consent form or could not obey the protocol.
- Patients who didn't received the CR or PR criterion.
- Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
- WBC <3000/mm3 in peripheral blood .
- Patients with central nervous system symptoms. -
Trial locations and contacts
1 site in 1 country.
China1 site
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, 210002
About this study
Official title: Research Institute of Nephrology, Jinling Hospital,
An multi-site, randomized, prospective study to compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza therapy.
Read the detailed description
Azathioprine (AZA) has been used for maintenance therapy of lupus nephritis for many years. We compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment vs CTX-Aza.
- Conditions
- Lupus Nephritis
- Being tested
- Multi-target therapy, Azathioprine
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-target therapyDrug
Also called Tacrolimus+mycophenolate mofetil
Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d)
AzathioprineDrug
Also called Aza
1.0-2.0mg/kg/d
| Study group | Role | What they receive |
|---|---|---|
| Multi-target therapy | Experimental | (Tarcrolimus+mycophenolate mofetil) Receives: Drug: Multi-target therapy |
| Azathioprine | Active comparator | Aza Receives: Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.
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 posted26 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies 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
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhi-Hong Liu, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhi-Hong Liu, M.D., Nanjing University School of Medicine
- Investigators
- zhihong Liu, Master, Principal investigator, Research Institute of Nephrology, Jinling Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056237
- Sponsor's protocol ID
- NJCT-1002
- Status last verified
- Jul 2015
- First submitted
- 21 Jan 2010
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Institute of Nephrology, Jinling Hospital,
- ClinicalTrials.gov ID
- NCT01056237
- Acronym / sponsor ID
- NJCT-1002
- Conditions
- Lupus Nephritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Zhi-Hong Liu, M.D.University, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Jan 2010 (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.
An multi-site, randomized, prospective study to compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza therapy.
Detailed description
Azathioprine (AZA) has been used for maintenance therapy of lupus nephritis for many years. We compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment vs CTX-Aza.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-target therapy | Experimental | Drug: Multi-target therapy(Tarcrolimus+mycophenolate mofetil) |
| Azathioprine | Active comparator | Drug: AzathioprineAza |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who signed written informed consent form
- SLE patient, aged between 18-65 years, female or male;
- Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy
- All patients had received induction therapy for 6 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
- Patients were recruited when received partial remission or complete remission after 6 months induction therapy.
Key exclusion criteria (5 listed)
- Patients who didn't sign written informed consent form or could not obey the protocol.
- Patients who didn't received the CR or PR criterion.
- Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
- WBC <3000/mm3 in peripheral blood .
- Patients with central nervous system symptoms. -
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 |
|---|---|---|
| Multi-target therapyAlso: Tacrolimus+mycophenolate mofetilTacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d) | Drug | Multi-target therapy |
| AzathioprineAlso: Aza1.0-2.0mg/kg/d | Drug | Azathioprine |
Primary outcome
To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.
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 31 Jul 2015.
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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.
zhihong Liu, Master principal investigator
Research Institute of Nephrology, Jinling Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-target therapy and Azathioprine in people with Lupus Nephritis, run by Zhi-Hong Liu, M.D. 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 6 inclusion and 5 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 31 Jul 2015. 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 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 compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2015.