Lupus NephritisPhase 3NCT02630628
Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis
A Phase 3 study testing Tacrolimus and Mycophenolate mofetil in people with Lupus Nephritis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Prospective, randomized, parallel-group controlled, open-label, international (Asian) multicenter, comparison of corticosteroids combined with tacrolimus and corticosteroids combined with mycophenolate mofetil. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Tacrolimus and Mycophenolate mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Dec 2015to 27 Dec 2024
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven LN Class III/IV±V (ISN/RPS 2003), with biopsy performed within 12 weeks of randomization.
- Positive anti-dsDNA.
- Active LN with proteinuria (urine protein/creatinine ratio ≥1.0 or 24-hr urine protein ≥1.0 g at baseline), with or without hematuria.
- Both 'incident' (i.e. new) patients and 'flare' patients can be included.
- Males or females aged 18 to 75 years inclusive at the time of screening.
Who cannot join
- Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial disease, renovascular disease), or transplanted kidney.
- Estimated glomerular filtration rate (eGFR by MDRD) ≤20 mL/min per 1.73 m2 or serum creatinine ≥300 micromol/L (3.39 mg/dL) at screening.
- Renal biopsy showing cellular or fibrocellular crescent in more than 25% of glomeruli.
- CNS or other severe organ manifestation of lupus that necessitate aggressive immunosuppressive therapy on its own.
- Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease).
- Treatment with prednisolone (or prednisone, or equivalent) at ≥20 mg/D for over 4 weeks within the past 3 months.
Show all 13Show fewer
- Treatment with MMF at >1.5 g/D for over 4 weeks within the past 3 months.
- Known hypersensitivity or intolerability to prednisolone (or prednisone, or equivalent), TAC, or MMF at a dose of 1.25 g or below per day.
- Subjects who are already on treatment with TAC, cyclosporine or any other calcineurin inhibitor on the day of screening; or have received treatment with TAC, cyclosporine or other calcineurin inhibitor for over 4 weeks within the past 6 months.
- Treatment with cyclophosphamide, leflunomide, or methotrexate for over 2 weeks, or use of biological agent(s) regardless of duration, within the past 6 months (Note: prior use of azathioprine, mizoribine, intravenous immunoglobulins and anti-malarials is allowed).
- Uncontrolled hypertension with systolic BP >160 mmHg or diastolic BP >95 mmHg.
- Women who are pregnant or breastfeeding.
- Women with childbearing potential or their male partners, who refuse to use an effective birth control method
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV±V Lupus Nephritis
Prospective, randomized, parallel-group controlled, open-label, international (Asian) multicenter, comparison of corticosteroids combined with tacrolimus and corticosteroids combined with mycophenolate mofetil.
Read the detailed description
There is accumulating evidence that tacrolimus (TAC) could serve as an effective medication for the treatment of lupus nephritis (LN). TAC is a calcineurin inhibitor, which is a key component in first-line combination immunosuppressive regimens after kidney transplantation, based on its proven efficacy in the prevention and treatment of allograft rejection and acceptable tolerability profile. Although it primarily targets T lymphocyte activation, its immunosuppressive actions encompass multiple immune response pathways due to the complex interactions between different cellular and soluble immune mediators. Moreover, the effect of calcineurin inhibitors on podocyte morphology and function, independent of their immunosuppressive effect, has translated into therapeutic efficacy in the treatment of proteinuric glomerular diseases such as membranous nephropathy and focal segmental glomerulosclerosis. Recent data from short-term studies showed that combination immunosuppressive regimens that included TAC and corticosteroids with or without mycophenolate mofetil (MMF) appeared at least as effective as other standard-of-care treatments for Class III/IV±V LN, and the inclusion of TAC might lead to more effective suppression of proteinuria. There is also preliminary data on its favorable tolerability when used as long-term maintenance treatment. This study aims to examine the role of TAC combined with corticosteroids, in comparison with the most commonly used standard-of-care treatment MMF plus corticosteroids, in the management of lupus nephritis.
- Conditions
- Lupus Nephritis
- Being tested
- Tacrolimus, Mycophenolate mofetil
- Keywords
- Lupus Nephritis, mycophenolate mofetil, tacrolimus
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf
Dosage: start at 2mg twice a day, then titrated according to therapeutic drug level monitoring using 12-hour post-dose blood sampling
Also called Cellcept
Dosage: start at 1g twice a day, then taper as per protocol
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Experimental | route: oral duration: 96 weeks Receives: Drug: Tacrolimus |
| Mycophenolate Mofetil | Active comparator | route: oral duration: 96 weeks Receives: Drug: Mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of combined corticosteroids and TAC compared to combined corticosteroids and MMF in achieving sustained renal response (RR) in patients with active lupus nephritis [Class III/IV±V (LN)]
Sustained RR defined as satisfying all of the following criteria:
- proteinuria improved by ≥50% compared with baseline
- 24-hr urine protein <1 g
- serum creatinine not higher than 15% above baseline level or eGFR not less than 60 mL/min/1.73m2
- no occurrence of disease flare AFTER achieving response to treatment. Disease flare is defined as the need for 'rescue' immunosuppressive therapy with any one of the following i. increase of prednisolone dose from ≤7.5 mg/D to ≥15 mg/D for 4 weeks or longer ii. change of originally assigned immunosuppressive agent iii. addition of immunosuppressive medications prohibited in protocol
Measured: 96 weeks
Secondary outcomes (24)
Rate of complete renal remission
- proteinuria not higher than 0.5 g/D
- serum creatinine not higher than 15% above baseline level or eGFR not less than 60 mL/min/1.73m2
Measured: 96 weeks
Rate of partial renal remission
- proteinuria above 0.5 g/D and below 3 g/D and with ≥50% improvement compared with baseline level
- serum creatinine not higher than 15% above baseline level or eGFR not less than 60 mL/min/1.73m2
Measured: 96 weeks
Efficacy of combined corticosteroids and TAC compared to combined corticosteroids and MMF in achieving sustained renal response (RR) in patients with active lupus nephritis [Class III/IV±V (LN)]
Sustained RR defined as satisfying all of the following criteria:
- proteinuria improved by ≥50% compared with baseline
- 24-hr urine protein <1 g
- serum creatinine not higher than 15% above baseline level or eGFR not less than 60 mL/min/1.73m2
- no occurrence of disease flare AFTER achieving response to treatment. Disease flare is defined as the need for 'rescue' immunosuppressive therapy with any one of the following i. increase of prednisolone dose from ≤7.5 mg/D to ≥15 mg/D for 4 weeks or longer ii. change of originally assigned immunosuppressive agent iii. addition of immunosuppressive medications prohibited in protocol
Measured: 48 weeks
Refractory disease
Never achieving partial renal remission since commencement of study
Measured: 96 weeks
Rate of non-renal flare
Disease flare defined by the need for 'rescue' immunosuppressive therapy with any one of the following i. increase of prednisolone dose from ≤7.5 mg/D to ≥15 mg/D for 4 weeks or longer ii. change of originally assigned immunosuppressive agent iii. addition of immunosuppressive medications prohibited in protocol
Measured: 96 weeks
Incidence of acute kidney injury
Number of patients who had increase of serum creatinine level ≥15% from baseline and whether the increase was reversible or irreversible
Measured: 96 weeks
Incidence of TAC blood level above target range
Number of patients who had 12-hour post dose TAC blood level above i. 8 ng/mL (from baseline to end of week 24) ii. 7 ng/mL (from start of week 25 to end of week 48, and from start of week 49 to end of week 96 for patients who had serum creatinine level <150 micromol/L) iii. 6 ng/mL (from start of week 49 to end of week 96 for patients who had serum creatinine level ≥150 micromol/L)
Measured: 96 weeks
Incidence of new onset hypertension or worsening hypertensive control
Number of patients who had new onset hypertension (blood pressure >140/90 mmHg) or worsening hypertensive control that required increase of number or dose of anti-hypertensive medications
Measured: 96 weeks
Rate of infection
Number of patients who had infection that required hospitalization and its causative agents
Measured: 96 weeks
Rate of Hospitalization
Number of patients who had been hospitalized, the cause and duration of hospitalization
Measured: 96 weeks
Incidence of hyperkalemia
Number of patients who had serum potassium level >5.6 mmol/L
Measured: 96 weeks
Incidence of metabolic acidosis
Number of patients who had serum bicarbonate level <17 mmol/L
Measured: 96 weeks
Incidence of new onset diabetes mellitus
Number of patients who had fasting glucose > 6.0 mmol/L and/or required addition of blood glucose lowering drug(s)
Measured: 96 weeks
Incidence of new onset hypercholesterolemia
Number of patients who had total cholesterol> 5.0 mmol/L and low density lipoprotein >3.4 mmol/L presented at 6 months or beyond from baseline and/or required addition of lipid-lowering drug(s)
Measured: 96 weeks
Rate of treatment intolerance leading to premature study discontinuation
Definition of treatment intolerance i. severe gastrointestinal disturbance or marrow suppression (white blood cell count <2×10^9/L OR platelet count <50×10^9/L OR hemoglobin <8 g/dL) judged due to MMF and persisted despite reduction of MMF dosage to < 1.25 g per day ii. significant hand-tremor or neurotoxicity related to TAC
Measured: 96 weeks
Rate of disease complication leading to premature study discontinuation
Number of patients who developed complication that led to premature study discontinuation
Measured: 96 weeks
Rate of disease flare leading to premature study discontinuation
Disease flare is defined as the need for 'rescue' immunosuppressive therapy with any one of the following i. increase of prednisolone dose from ≤7.5 mg/D to ≥15 mg/D for 4 weeks or longer ii. change of originally assigned immunosuppressive agent iii. addition of immunosuppressive medications prohibited in protocol
Measured: 96 weeks
Number of patients who failed to adhere to protocol defined corticosteroid reduction regimen
Failure to adhere to corticosteroid reduction regimen was defined as deviation from protocol-defined corticosteroid dose by >5mg/D for >3 weeks due to unsatisfactory treatment response or new-onset disease activity.
Measured: 96 weeks
Incidence of adverse events
Number and type of adverse events, irrespective of whether the event was treatment-related or not
Measured: 96 weeks
Incidence of serious adverse events
Number and type of serious adverse events, irrespective of whether the event was treatment-related or not
Measured: 96 weeks
Changes in SELENA-SLEDAI scores
Changes in SELENA-SLEDAI scores from baseline to week 96
Measured: 96 weeks
Changes in PGA scores
Changes in PGA scores from baseline to week 96
Measured: 96 weeks
Changes in SFI scores
Changes in SFI scores from baseline to week 96
Measured: 96 weeks
Changes in BILAG (2004) scores
Changes in BILAG (2004) scores from baseline to week 96
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study start5 Dec 2015
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
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 Lupus NephritisStudies of the same condition, open and under way.
- More trials run by The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Daniel Tak-Mao Chan, The University of Hong Kong
- Investigators
- Tak-Mao Daniel Chan, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630628
- Sponsor's protocol ID
- ALNN-IIS-17JUL15-1
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2015
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yap DYH, Navarra SV, Ni Z, Avihingsanon Y, Lim SK, Zhi H, Takeuchi T, Teck A Liew S, Chan SCW, Chan C, Wu JS, Jiang N, Liu WJ, Chen W, Li C, Zhang C, Theresa M Collante M, Zamora L, Kikuchi J, Yung S, Chan TM; for Asian Lupus Nephritis Network Investigators. Prospective 96-week study to evaluate efficacy and safety of tacrolimus and glucocorticoid against mycophenolate and glucocorticoid as continuous induction-maintenance treatment for Class III/IV without or with Class V lupus nephritis. Kidney Int. 2026 Sep 28:S0085-2538(26)00817-3. doi: 10.1016/j.kint.2026.08.026. Online ahead of print.
PubMed 42805336
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV±V Lupus Nephritis
- ClinicalTrials.gov ID
- NCT02630628
- Acronym / sponsor ID
- ALNN-IIS-17JUL15-1
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis, mycophenolate mofetil, tacrolimus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 5 Dec 2015 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 15 Dec 2015 (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.
Prospective, randomized, parallel-group controlled, open-label, international (Asian) multicenter, comparison of corticosteroids combined with tacrolimus and corticosteroids combined with mycophenolate mofetil.
Detailed description
There is accumulating evidence that tacrolimus (TAC) could serve as an effective medication for the treatment of lupus nephritis (LN). TAC is a calcineurin inhibitor, which is a key component in first-line combination immunosuppressive regimens after kidney transplantation, based on its proven efficacy in the prevention and treatment of allograft rejection and acceptable tolerability profile. Although it primarily targets T lymphocyte activation, its immunosuppressive actions encompass multiple immune response pathways due to the complex interactions between different cellular and soluble immune mediators. Moreover, the effect of calcineurin inhibitors on podocyte morphology and function, independent of their immunosuppressive effect, has translated into therapeutic efficacy in the treatment of proteinuric glomerular diseases such as membranous nephropathy and focal segmental glomerulosclerosis. Recent data from short-term studies showed that combination immunosuppressive regimens that included TAC and corticosteroids with or without mycophenolate mofetil (MMF) appeared at least as effective as other standard-of-care treatments for Class III/IV±V LN, and the inclusion of TAC might lead to more effective suppression of proteinuria. There is also preliminary data on its favorable tolerability when used as long-term maintenance treatment. This study aims to examine the role of TAC combined with corticosteroids, in comparison with the most commonly used standard-of-care treatment MMF plus corticosteroids, in the management of lupus nephritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | Experimental | Drug: Tacrolimusroute: oral duration: 96 weeks |
| Mycophenolate Mofetil | Active comparator | Drug: Mycophenolate mofetilroute: oral duration: 96 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy-proven LN Class III/IV±V (ISN/RPS 2003), with biopsy performed within 12 weeks of randomization.
- Positive anti-dsDNA.
- Active LN with proteinuria (urine protein/creatinine ratio ≥1.0 or 24-hr urine protein ≥1.0 g at baseline), with or without hematuria.
- Both 'incident' (i.e. new) patients and 'flare' patients can be included.
- Males or females aged 18 to 75 years inclusive at the time of screening.
Key exclusion criteria (13 listed)
- Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial disease, renovascular disease), or transplanted kidney.
- Estimated glomerular filtration rate (eGFR by MDRD) ≤20 mL/min per 1.73 m2 or serum creatinine ≥300 micromol/L (3.39 mg/dL) at screening.
- Renal biopsy showing cellular or fibrocellular crescent in more than 25% of glomeruli.
- CNS or other severe organ manifestation of lupus that necessitate aggressive immunosuppressive therapy on its own.
- Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease).
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: PrografDosage: start at 2mg twice a day, then titrated according to therapeutic drug level monitoring using 12-hour post-dose blood sampling | Drug | Tacrolimus |
| Mycophenolate mofetilAlso: CellceptDosage: start at 1g twice a day, then taper as per protocol | Drug | Mycophenolate Mofetil |
Primary outcome
Efficacy of combined corticosteroids and TAC compared to combined corticosteroids and MMF in achieving sustained renal response (RR) in patients with active lupus nephritis [Class III/IV±V (LN)]
Time frame: 96 weeks
Sustained RR defined as satisfying all of the following criteria: 1. proteinuria improved by ≥50% compared with baseline 2. 24-hr urine protein <1 g 3. serum creatinine not higher than 15% above baseline level or eGFR not less than 60 mL/min/1.73m2 4. no occurrence of disease flare AFTER achieving response to treatment. Disease flare is defined as the need for 'rescue' immunosuppressive therapy with any one of the following i. increase of prednisolone dose from ≤7.5 mg/D to ≥15 mg/D for 4 weeks or longer ii. change of originally assigned immunosuppressive agent iii. addition of immunosuppressive medications prohibited in protocol
24 secondary outcomes
Rate of complete renal remission
Time frame: 96 weeks
Rate of partial renal remission
Time frame: 96 weeks
Efficacy of combined corticosteroids and TAC compared to combined corticosteroids and MMF in achieving sustained renal response (RR) in patients with active lupus nephritis [Class III/IV±V (LN)]
Time frame: 48 weeks
Refractory disease
Time frame: 96 weeks
Rate of non-renal flare
Time frame: 96 weeks
Incidence of acute kidney injury
Time frame: 96 weeks
Incidence of TAC blood level above target range
Time frame: 96 weeks
Incidence of new onset hypertension or worsening hypertensive control
Time frame: 96 weeks
Rate of infection
Time frame: 96 weeks
Rate of Hospitalization
Time frame: 96 weeks
Incidence of hyperkalemia
Time frame: 96 weeks
Incidence of metabolic acidosis
Time frame: 96 weeks
Incidence of new onset diabetes mellitus
Time frame: 96 weeks
Incidence of new onset hypercholesterolemia
Time frame: 96 weeks
Rate of treatment intolerance leading to premature study discontinuation
Time frame: 96 weeks
Rate of disease complication leading to premature study discontinuation
Time frame: 96 weeks
Rate of disease flare leading to premature study discontinuation
Time frame: 96 weeks
Number of patients who failed to adhere to protocol defined corticosteroid reduction regimen
Time frame: 96 weeks
Incidence of adverse events
Time frame: 96 weeks
Incidence of serious adverse events
Time frame: 96 weeks
Changes in SELENA-SLEDAI scores
Time frame: 96 weeks
Changes in PGA scores
Time frame: 96 weeks
Changes in SFI scores
Time frame: 96 weeks
Changes in BILAG (2004) scores
Time frame: 96 weeks
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 25 Sep 2025.
- Derived from this study: PubMed 42805336Yap DYH, Navarra SV, Ni Z, Avihingsanon Y, Lim SK, Zhi H, Takeuchi T, Teck A Liew S, Chan SCW, Chan C, Wu JS, Jiang N, Liu WJ, Chen W, Li C, Zhang C, Theresa M Collante M, Zamora L, Kikuchi J, Yung S, Chan TM; for Asian Lupus Nephritis Network Investigators. Prospective 96-week study to evaluate efficacy and safety of tacrolimus and glucocorticoid against mycophenolate and glucocorticoid as continuous induction-maintenance treatment for Class III/IV without or with Class V lupus nephritis. Kidney Int. 2026 Sep 28:S0085-2538(26)00817-3. doi: 10.1016/j.kint.2026.08.026. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Tak-Mao Daniel Chan principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus and Mycophenolate mofetil in people with Lupus Nephritis, run by The 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 5 inclusion and 13 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 25 Sep 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy of combined corticosteroids and TAC compared to combined corticosteroids and MMF in achieving sustained renal response (RR) in patients with active lupus nephritis [Class III/IV±V (LN)] (time frame: 96 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 NCT02630628, 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 25 Sep 2025.