Immunoglobulin A NephropathyPhase 2SPARTANNCT04663204
A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy
A Phase 2 study testing Sparsentan in people with Immunoglobulin A Nephropathy and Kidney Diseases, run by University of Leicester at 6 sites in United Kingdom.
Trial summary
To determine the nephroprotective potential of treatment with sparsentan in (1: Cohort A) patients newly-diagnosed with immunoglobulin A nephropathy (IgAN) (ie, incident patients) who have not received prior angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy, and in (2: Cohort… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoglobulin A Nephropathy, Kidney Diseases, Glomerulonephritis, IGA
- What is being tested?
- Sparsentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 10 Dec 2020to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is willing and able to provide signed informed consent.
- The patient can understand written and spoken English.
- The patient is male or female, aged ≥18 years.
- The patient has been diagnosed with biopsy-proven IgAN within the last 6 months (calculated from the date of kidney biopsy, upon which the IgAN-positive diagnosis was made, to the signing of the informed consent form).
- The patient has a urine total protein value ≥0.5 g/day at screening.
- The patient has an eGFR value ≥30 mL/min/1.73 m2 at screening.
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- The patient has not previously been treated with ACEI and/or ARB therapy for IgAN OR has not received ACEI and/or ARB therapy within the last 12 months.
- The patient has a systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening.
- Women of childbearing potential (WOCBP), beginning at menarche, must agree to the use of one highly reliable (ie, can achieve a failure rate of <1% per year) method of contraception from 7 days prior to the first dose of trial medication until 90 days after the last dose of trial medication. Highly reliable contraception methods include stable oral, implanted, transdermal, or injected contraceptive hormones associated with inhibition of ovulation, or an intrauterine device (IUD) in place for at least 3 months. One additional barrier method must also be used during sexual activity, such as a diaphragm or diaphragm with spermicide (preferred), or male partner's use of male condom or male condom with spermicide), from Day 1 until 90 days after the last dose of trial medication.
- WOCBP are defined as those who are fertile, following menarche and until becoming postmenopausal unless permanently sterile; permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as amenorrhoea for more than 24 consecutive months without an alternative medical cause; women on hormone replacement therapy must have a documented plasma follicle-stimulating hormone level ≥40 mIU/mL. All WOCBP must have a negative pregnancy test at Visit 1 (serum test) and Visit 2 (urine, with positive results confirmed by serum).
- Male and female aged ≥18 years
- Diagnosis of recurrent IgAN based on histological analysis of a transplanted kidney biopsied within the last 6 months
- A time period of >12 months since kidney transplantation
- UPCR ≥50 mg/mmol (≥0.44 g/g) and eGFR value ≥25 mL/min/1.73 m2
- For patients on an ACEI and/or ARB, and/or SGLT2 inhibitor, the dosing regimen is stable for at least 6 weeks prior to and during the screening period
- Tacrolimus treatment as part of standard of care immunosuppression following kidney transplantation
- Systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening.
- Female patients not of childbearing potential, or of childbearing potential and agreeing to use the contraceptive methods listed in Section 5.1
Who cannot join
- The patient has IgAN secondary to another condition (eg, systemic lupus erythematosus, liver cirrhosis).
- The patient, in the opinion of the Investigator, has a rapidly progressive glomerulonephritis (rapid decline in GFR and crescents on biopsy).
- The patient has a history of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (haemoglobin A1c [HbA1c] >8%), or nonfasting blood glucose >10 mmol/L (180 mg/dL) at screening.
- The patient has undergone any organ transplantation, with the exception of corneal transplants.
- The patient requires any of the prohibited concomitant medications (see Section 14.4).
- The patient has been taking any systemic immunosuppressive medications for >2 weeks within 6 months prior to screening.
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- The patient has a documented history of heart failure (New York Heart Association Class II-IV) and/or previous hospitalisation for heart failure or unexplained dyspnoea, orthopnoea, paroxysmal nocturnal dyspnoea, ascites, and/or peripheral oedema.
- The patient has clinically significant cerebrovascular disease (transient ischemic attack or stroke) and/or coronary artery disease (hospitalisation for myocardial infarction or unstable angina, new onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary revascularisation procedure) within 6 months prior to screening.
- The patient has jaundice, hepatitis, or known hepatobiliary disease (including asymptomatic cholelithiasis), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of the normal range at screening.
- The patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.
- The patient has a screening haematocrit value <27% or haemoglobin value <90 g/L (9 g/dL).
- The patient has a screening potassium value of >5.5 mmol/L (5.5 mEq/L).
- The patient has a history of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition).
- The patient has a history of serious side effects or allergic response to any AngII or ERA, including sparsentan, or has a hypersensitivity to any of the excipients in the IMP.
- The female patient is pregnant, plans to become pregnant during the course of the trial, or is breastfeeding.
- The patient has participated in a trial of any investigational product within 28 days prior to screening, or plans to participate in such a trial during the course of this trial.
- The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the trial, including the ability to swallow the IMP whole.
- The patient, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.
- Patients with a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity will be reviewed before consideration of the patient for enrolment.
- For Cohort B (Recurrent IgAN following kidney transplantation)
- The patient has recurrent IgAN secondary to another condition or cause (eg, systemic lupus erythematosus, liver cirrhosis).
- Evidence of alternative pathology on the kidney transplant biopsy as the main cause for proteinuria (e.g. diabetic nephropathy, chronic transplant glomerulopathy, mTORi treatment)
- Patient has multiorgan transplants (with the exception of corneal transplants)
- Immunosuppressive therapy (IST) regimen for kidney transplant or other chronic immunosuppressive therapies that is not stable for >6 weeks prior to Day 1. Exceptions include routine protocol tapering and for tacrolimus, changes in dose to meet target level
- Treatment with enteric budesonide (nefecon) within 6 months prior to screening, or planned use of enteric budesonide (nefecon) at any time during the study.
- Current treatment for surgical complications
- <3 months after anti-rejection treatment or active rejection
- Active bacterial, fungal or viral infection and/or active treatment of infection including BKV, CMV, HIV, Hepatitis B and C <3 months prior to and during the screening period
- Current treatment for surgical complications
- Uncontrolled diabetes mellitus (defined by HbA1C >8% (>64 mmol/mol)
- History of heart failure (New York Heart Association (NYHA) Class II-IV)
- Jaundice, hepatitis, or known hepatobiliary disease
- Malignancy within the past 2 years with the exception of adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin, with no evidence or recurrence
- Haematocrit <27%, haemoglobin <90 g/L (9 g/dL), or potassium >5.5 mmol/L (5.5 mEq/L)
- History of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition)
- History of serious side effects or allergic response to any angiotensin II antagonist or endothelin receptor antagonist (ERA) or dual endothelin and angiotensin receptor antagonist (DEARA e.g. sparsentan)
- The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
- The patient has participated in a study of any investigational product within 28 days prior to screening, or plans to participate in such a study during the course of this study.
- The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the IMP whole.
- The patient, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United Kingdom6 sites, 6 recruiting
- Recruiting
Cambridge University Hospitals NHS Trust
Cambridge, England
- Recruiting
University Hospital of wales
Cardiff, Wales, CF14 4XW
- Recruiting
Royal Infirmary of Edinburgh & Western General Hospital
Edinburgh, Scotland
- Recruiting
Leicester General Hospital, University Hospitals of Leicester NHS Trust
Leicester, LE5 4PW
Justyna Szklarzewicz, +44 116 258 4351, justyna.szklarzewicz@uhl-tr.nhs.uk
Chee Kay Cheung, MBChB PhD
- Recruiting
King's College Hospital
London
- Recruiting
Northern Care Alliance NHS Foundation Trust - Salford Royal
Salford, England
About this study
Official title: A Multi-centre, Open-label, Exploratory Trial of the Safety and Activity of Sparsentan for the Treatment of Incident (Cohort A) and Recurrent (Cohort B) Patients With Immunoglobulin A Nephropathy
To determine the nephroprotective potential of treatment with sparsentan in (1: Cohort A) patients newly-diagnosed with immunoglobulin A nephropathy (IgAN) (ie, incident patients) who have not received prior angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy, and in (2: Cohort B) patients with recurrent IgAN following kidney transplantation.
Read the detailed description
This multi-centre, open-label trial will explore the safety of, and response to sparsentan treatment in adult patients with biopsy-proven immunoglobulin A nephropathy (IgAN).
In Cohort A, incident, renin angiotensin system (RAS) blockade-naïve patients will be included. The starting dose of sparsentan will be 200 mg/day, which will be titrated up to the target dose of 400 mg/day at Week 2. Patients who do not tolerate the target dose will have their dose reduced back to 200 or 100 mg/day; throughout the trial, patients will be maintained on the maximum allowed dose of sparsentan they can tolerate. All patients will be treated with sparsentan for a total of 110 weeks, followed by an off-treatment follow-up period of 4 weeks. Urinary protein excretion, estimated and measured glomerular filtration rate (GFR), Oxford Classification (MEST-C) for renal biopsies, magnetic resonance imaging (MRI) for renal interstitial fibrosis and cardiac function, and bioimpedance spectroscopy for total body water will be assessed. Quality of Life (QOL) will also be assessed. Treatment with additional antihypertensive agents is permitted during the trial, with the exception of angiotensin-converting enzyme inhibitors (ACEIs), aldosterone blockers, aliskiren, or angiotensin receptor blockers (ARBs). Safety will be assessed by adverse events (AEs), clinical laboratory evaluations, and vital signs.
In Cohort B, patients with recurrent IgAN following kidney transplantation receiving stable standard of care (SOC) therapy, including standard immunosuppressive therapy (that includes tacrolimus) to prevent graft rejection, will be randomly assigned in a 1:1 ratio to receive sparsentan in addition to SOC therapy for 48 weeks or to remain on SOC therapy for the first 24 weeks after which sparsentan will be added to SOC therapy for the second 24 weeks of the study. All patients will stop ACEIs, ARBs, aldosterone blockers or aliskiren prior to initiating sparsentan treatment. All patients will complete a 4-week follow-up period, during which time treatment will be at the discretion of the investigator. Urinary protein excretion, estimated GFR (eGFR), Oxford Classification (MEST-C) for renal biopsies will be assessed, as well as measurement of tacrolimus levels during the trial. Safety will be assessed by adverse events (AEs), clinical laboratory evaluations, and vital signs.
- Conditions
- Immunoglobulin A Nephropathy, Kidney Diseases, Glomerulonephritis, IGA, Glomerulonephritis, Autoimmune Diseases, Immune System Diseases
- Being tested
- Sparsentan
- Medical subject headings
- Glomerulonephritis, IGA, Kidney Diseases, Glomerulonephritis, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SparsentanDrug
Also called RE-021
Target dose of 400 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Sparsentan | Experimental | Sparsentan will be administered once daily, starting at a dose of 200 mg (two 100 mg oral capsules) for the first 2 weeks of the study. Patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400 mg (one 400 mg tablet). Patients who do not tolerate the target dose will have their dose reduced back to 200 or 100 mg/day; throughout the study, patients will be maintained on the maximum allowed dose of sparsentan they can tolerate. All patients will be treated with sparsentan for a total of 110 weeks. Receives: Drug: Sparsentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine protein/creatinine ratio (UP/C) at Week 36
The primary efficacy endpoint is the change from baseline in the urine protein/creatinine ratio (UP/C), based on a 24-hour urine sample, at Week 36.
Measured: Week 36
Secondary outcomes (5)
eGFR over a 52-week period
Rate of change in eGFR over a 1-year (52 week) period following the initial acute effect of therapy (ie, from 6 weeks post-initiation of investigational medicinal product (IMP) to 58 weeks post-initiation of IMP).
Measured: Week 58
eGFR over a 104-week period
Rate of change in eGFR over a 2-year (104 week) period following the initial acute effect of therapy (ie, from 6 weeks post-initiation of investigational medicinal product (IMP) to 110 weeks post-initiation of IMP).
Measured: Week 110
Change from baseline in proteinuria
Change from baseline in proteinuria, measured by urinary protein/creatinine ratio [UPCR] and 24-hour protein excretion, up to Week 114
Measured: Up to Week 114
Abnormalities in clinical laboratory assessments and vital signs
Proportion of patients with abnormalities in clinical laboratory assessments and vital signs at each visit
Measured: Up to Week 114
Incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation, AEs leading to death
AEs, serious AEs, AEs leading to discontinuation, AEs leading to death
Measured: Up to Week 114
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start10 Dec 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin A 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Travere Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Chee Kay Cheung, MBChB PhD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663204
- Sponsor's protocol ID
- 0708
- Other IDs
- 2018-002012-27, 257450, 2018
- Acronym
- SPARTAN
- Status last verified
- May 2026
- First submitted
- 8 Dec 2020
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Open-label, Exploratory Trial of the Safety and Activity of Sparsentan for the Treatment of Incident (Cohort A) and Recurrent (Cohort B) Patients With Immunoglobulin A Nephropathy
- ClinicalTrials.gov ID
- NCT04663204
- Acronym / sponsor ID
- SPARTAN / 0708
- Conditions
- Immunoglobulin A Nephropathy, Kidney Diseases, Glomerulonephritis, IGA, Glomerulonephritis, Autoimmune Diseases, Immune System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Travere Therapeutics, Inc.
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Dec 2020 (actual)
- 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.
To determine the nephroprotective potential of treatment with sparsentan in (1: Cohort A) patients newly-diagnosed with immunoglobulin A nephropathy (IgAN) (ie, incident patients) who have not received prior angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy, and in (2: Cohort B) patients with recurrent IgAN following kidney transplantation.
Detailed description
This multi-centre, open-label trial will explore the safety of, and response to sparsentan treatment in adult patients with biopsy-proven immunoglobulin A nephropathy (IgAN).
In Cohort A, incident, renin angiotensin system (RAS) blockade-naïve patients will be included. The starting dose of sparsentan will be 200 mg/day, which will be titrated up to the target dose of 400 mg/day at Week 2. Patients who do not tolerate the target dose will have their dose reduced back to 200 or 100 mg/day; throughout the trial, patients will be maintained on the maximum allowed dose of sparsentan they can tolerate. All patients will be treated with sparsentan for a total of 110 weeks, followed by an off-treatment follow-up period of 4 weeks. Urinary protein excretion, estimated and measured glomerular filtration rate (GFR), Oxford Classification (MEST-C) for renal biopsies, magnetic resonance imaging (MRI) for renal interstitial fibrosis and cardiac function, and bioimpedance spectroscopy for total body water will be assessed. Quality of Life (QOL) will also be assessed. Treatment with additional antihypertensive agents is permitted during the trial, with the exception of angiotensin-converting enzyme inhibitors (ACEIs), aldosterone blockers, aliskiren, or angiotensin receptor blockers (ARBs). Safety will be assessed by adverse events (AEs), clinical laboratory evaluations, and vital signs.
In Cohort B, patients with recurrent IgAN following kidney transplantation receiving stable standard of care (SOC) therapy, including standard immunosuppressive therapy (that includes tacrolimus) to prevent graft rejection, will be randomly assigned in a 1:1 ratio to receive sparsentan in addition to SOC therapy for 48 weeks or to remain on SOC therapy for the first 24 weeks after which sparsentan will be added to SOC therapy for the second 24 weeks of the study. All patients will stop ACEIs, ARBs, aldosterone blockers or aliskiren prior to initiating sparsentan treatment. All patients will complete a 4-week follow-up period, during which time treatment will be at the discretion of the investigator. Urinary protein excretion, estimated GFR (eGFR), Oxford Classification (MEST-C) for renal biopsies will be assessed, as well as measurement of tacrolimus levels during the trial. Safety will be assessed by adverse events (AEs), clinical laboratory evaluations, and vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sparsentan | Experimental | Drug: SparsentanSparsentan will be administered once daily, starting at a dose of 200 mg (two 100 mg oral capsules) for the first 2 weeks of the study. Patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400 mg (one 400 mg tablet). Patients who do not tolerate the target dose will have their dose reduced back to 200 or 100 mg/day; throughout the study, patients will be maintained on the maximum allowed dose of sparsentan they can tolerate. All patients will be treated with sparsentan for a total of 110 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The patient is willing and able to provide signed informed consent.
- The patient can understand written and spoken English.
- The patient is male or female, aged ≥18 years.
- The patient has been diagnosed with biopsy-proven IgAN within the last 6 months (calculated from the date of kidney biopsy, upon which the IgAN-positive diagnosis was made, to the signing of the informed consent form).
- The patient has a urine total protein value ≥0.5 g/day at screening.
Key exclusion criteria (40 listed)
- The patient has IgAN secondary to another condition (eg, systemic lupus erythematosus, liver cirrhosis).
- The patient, in the opinion of the Investigator, has a rapidly progressive glomerulonephritis (rapid decline in GFR and crescents on biopsy).
- The patient has a history of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (haemoglobin A1c [HbA1c] >8%), or nonfasting blood glucose >10 mmol/L (180 mg/dL) at screening.
- The patient has undergone any organ transplantation, with the exception of corneal transplants.
- The patient requires any of the prohibited concomitant medications (see Section 14.4).
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 |
|---|---|---|
| SparsentanAlso: RE-021Target dose of 400 mg daily | Drug | Sparsentan |
Primary outcome
Urine protein/creatinine ratio (UP/C) at Week 36
Time frame: Week 36
The primary efficacy endpoint is the change from baseline in the urine protein/creatinine ratio (UP/C), based on a 24-hour urine sample, at Week 36.
5 secondary outcomes
eGFR over a 52-week period
Time frame: Week 58
eGFR over a 104-week period
Time frame: Week 110
Change from baseline in proteinuria
Time frame: Up to Week 114
Abnormalities in clinical laboratory assessments and vital signs
Time frame: Up to Week 114
Incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation, AEs leading to death
Time frame: Up to Week 114
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- 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.
Chee Kay Cheung, MBChB PhD principal investigator
University of Leicester
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sparsentan in people with Immunoglobulin A Nephropathy and Kidney Diseases, run by University of Leicester at 6 sites in United Kingdom.
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 18 inclusion and 40 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justyna Szklarzewicz (+44 116 258 4351, justyna.szklarzewicz@uhl-tr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine protein/creatinine ratio (UP/C) at Week 36 (time frame: Week 36). 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 3 Jun 2026.