Lupus NephritisPhase 4NCT01206569
Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
A Phase 4 study testing Long-acting tacrolimus (Advagraf, Astellas Pharma) in people with Lupus Nephritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). Around one-third of the patients, however, do not respond to conventional immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent renal failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Long-acting tacrolimus (Advagraf, Astellas Pharma)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2010to Feb 2012
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 with informed consent.
- Fulfill the revised American College of Rheumatology criteria for SLE
- Biopsy-proven class III, IV, or V lupus nephritis within the past 24 months.
- Could not achieve complete remission after at least 4 months of conventional therapy (oral steroid plus cyclosphosphamide or mycophenolate mofetil).
- NB. Complete response is defined as proteinuria less than 0.5 g/day, with normal urinary sediment, a normal serum albumin concentration, and serum creatinine <15% above the base-line value.
- Female patients of child-bearing age and male patients agree to maintain effective birth control practice during the study.
Who cannot join
- Abnormal liver function tests
- Hepatitis B surface antigen or hepatitis C antibody positive
- Diabetic
- Receiving NSAID or other agents known to influence urinary
- Protein excretion
- Allergic or intolerant to macrolide antibiotics or tacrolimus
Trial locations and contacts
1 site in 1 country.
About this study
Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). Around one-third of the patients, however, do not respond to conventional immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent renal failure. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm study the efficacy and safety of long-acting tacrolimus in the treatment of treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for 6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. This study will explore the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor prognosis and no effective treatment at the moment.
- Conditions
- Lupus Nephritis
- Being tested
- Long-acting tacrolimus (Advagraf, Astellas Pharma)
- Keywords
- glomerulonephritis, systemic lupus erythematosus
- Medical subject headings
- Lupus Nephritis, Glomerulonephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-acting tacrolimus (Advagraf, Astellas Pharma)Drug
Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| advagraf | Experimental | Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months. Receives: Drug: Long-acting tacrolimus (Advagraf, Astellas Pharma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall clinical response
complete response is defined as urinary protein < 0.5 g/day, with normal urinary sediment, normal serum albumin, and serum creatinine < 15% above the base-line value. Partial response is defined as urinary protein between 0.6 and 2.9 g/day, with a serum albumin > 30 g/dL, and stable renal function. No response is defined as urinary protein > 3 g/day or a value of 0.6 to 2.9 g/day but serum albumin < 30 g/dL, an increase in serum creatinine ≥ 50 µmol/l or 15% above the base-line value, or the discontinuation of treatment due to side effects.
Measured: 6 months
Secondary outcomes (4)
change in SLEDAI score
Measured: 6 months
24-hour urinary protein excretion
Measured: 6 months
renal function
Measured: 6 months
development of lupus flare (renal or non-renal)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionFeb 2012
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.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheuk-Chun SZETO, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206569
- Sponsor's protocol ID
- AFKLN
- Status last verified
- Dec 2012
- First submitted
- 21 Sep 2010
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
- ClinicalTrials.gov ID
- NCT01206569
- Acronym / sponsor ID
- AFKLN
- Conditions
- Lupus Nephritis
- Keywords
- glomerulonephritis, systemic lupus erythematosus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Sep 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.
Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). Around one-third of the patients, however, do not respond to conventional immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent renal failure. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm study the efficacy and safety of long-acting tacrolimus in the treatment of treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for 6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. This study will explore the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor prognosis and no effective treatment at the moment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| advagraf | Experimental | Drug: Long-acting tacrolimus (Advagraf, Astellas Pharma)Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 with informed consent.
- Fulfill the revised American College of Rheumatology criteria for SLE
- Biopsy-proven class III, IV, or V lupus nephritis within the past 24 months.
- Could not achieve complete remission after at least 4 months of conventional therapy (oral steroid plus cyclosphosphamide or mycophenolate mofetil).
- NB. Complete response is defined as proteinuria less than 0.5 g/day, with normal urinary sediment, a normal serum albumin concentration, and serum creatinine <15% above the base-line value.
Key exclusion criteria (6 listed)
- Abnormal liver function tests
- Hepatitis B surface antigen or hepatitis C antibody positive
- Diabetic
- Receiving NSAID or other agents known to influence urinary
- Protein excretion
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 |
|---|---|---|
| Long-acting tacrolimus (Advagraf, Astellas Pharma)Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months. | Drug | advagraf |
Primary outcome
overall clinical response
Time frame: 6 months
complete response is defined as urinary protein < 0.5 g/day, with normal urinary sediment, normal serum albumin, and serum creatinine < 15% above the base-line value. Partial response is defined as urinary protein between 0.6 and 2.9 g/day, with a serum albumin > 30 g/dL, and stable renal function. No response is defined as urinary protein > 3 g/day or a value of 0.6 to 2.9 g/day but serum albumin < 30 g/dL, an increase in serum creatinine ≥ 50 µmol/l or 15% above the base-line value, or the discontinuation of treatment due to side effects.
4 secondary outcomes
change in SLEDAI score
Time frame: 6 months
24-hour urinary protein excretion
Time frame: 6 months
renal function
Time frame: 6 months
development of lupus flare (renal or non-renal)
Time frame: 6 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 4 Dec 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Long-acting tacrolimus (Advagraf, Astellas Pharma) in people with Lupus Nephritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 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 4 Dec 2012. 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 Hong Kong. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
overall clinical response (time frame: 6 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 4 Dec 2012.