Lupus NephritisPhase 4PentoxifyllineNCT03859570
Pentoxifylline in Lupus Nephritis
A Phase 4 study testing Pentoxifylline in people with Lupus Nephritis, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
Glomerulonephritis is an important manifestation in about 1/2 of patients with Systemic Lupus Nephritis (SLE; lupus). Despite recent national guidelines recommending use of induction therapy with high-dose corticosteroids and immunosuppressive agents, followed by prolonged maintenance therapy, up to 1/3 of these… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Pentoxifylline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to Dec 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 and older, who meet the 1997 update of the1982 criteria for classification of systemic lupus erythematosus and have established lupus nephritis as documented by any of the following:
- Kidney biopsy documenting class II, III, IV, or V (RPS/ISN 2004) lupus nephritis within 3 years or
- Abnormal urine protein excretion on 2 occasions, at least 2 weeks apart, characterized by more than 500 mg urine protein, quantitated either by 24-hour urine collection or by urine protein/creatinine ratio (UPCR) more than 0.5 mg/mg, measured on a first void morning specimen, in the absence of other glomerulopathies; or
- Abnormal urine sediment, containing more than 5 RBC, more than 5 WBC, or cellular casts on 2 occasions, at least 2 weeks apart, in the absence of infection, concurrent menstruation, anatomic genitourinary abnormalities, or pathologic disorders other than lupus nephritis.
- Absence of changes in immunosuppressive agents or dose of immunosuppressive agents administered during the 2 months before enrollment. Patients with newly-diagnosed lupus nephritis will not be invited to participate until after they have completed 6 months of initial induction therapy.
- Unless contraindicated, patients will be required to be taking an ACE inhibitor or ARB, with stable dose for at least 1 month prior to enrollment. Patients with intolerance of ACE/ARB therapies will be eligible to participate, but will be analyzed separately, as indicated in the trial synopsis.
Show all 10Show fewer
- Urine protein more than 500 mg/24 hours and/or UPCR more than 0.5 mg/mg at time of baseline.
- Willingness to remain on stable immunosuppressive drugs for the 6-month duration of the study unless safety issues arise.
- The SELENA-SLEDAI will be measured at screening but no minimal SLEDAI score will be required for inclusion.
- Although kidney biopsy is not required for enrollment in this clinical trial, the standard of care at all participating institutions is to recommend renal biopsy for all patients with lupus nephritis, and generally at least 75% of such patients at each participating institution will be expected to have had this procedure. Subjects who qualify for this study according to clinical criteria noted in 1b and 1c above must be confirmed to have lupus nephritis, and no other renal disorder, by the site PI, prior to enrollment.
Who cannot join
- History of retinal, cerebral, or peptic ulcer hemorrhage within 3 months prior to enrollment
- Current use of warfarin, long-acting heparin, or an oral anti-coagulant (other than low dose aspirin)
- Pregnancy or currently breast-feeding
- History of theophylline, pentoxifylline, or caffeine allergy
- Currently taking theophylline-containing medications
- Malignancy within 2 years, other than basal cell carcinoma
Show all 16Show fewer
- Congestive heart failure, class III or IV
- Abnormal AST/ALT, more than 2 times ULN
- Obstructive uropathy
- Acute kidney injury defined as greater than 50% decrease in GFR within 30 days prior to screening.
- Myocardial infarction, percutaneous coronary intervention, coronary bypass graft surgery, or unstable angina within 6 months prior to screening
- BP greater than 150/95 on 2 measurements in the sitting position after 5 minutes of rest, using a manual BP cuff
- Known diagnosis of diabetes mellitus or hemoglobin A1c greater than 8.0
- Current (within 3 months) GFR less than 30 mL/min
- Surgery within 3 months prior to enrollment
- Concurrent diagnosis of antiphospholipid syndrome (APS), or presence of APS antibodies on 2 occasions, more than 12 weeks apart.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized Trial of Pentoxifylline or Placebo in Addition to Standard of Care for Treatment of Proteinuria in Patients With Lupus Nephritis.
Glomerulonephritis is an important manifestation in about 1/2 of patients with Systemic Lupus Nephritis (SLE; lupus). Despite recent national guidelines recommending use of induction therapy with high-dose corticosteroids and immunosuppressive agents, followed by prolonged maintenance therapy, up to 1/3 of these patients continue to have active nephritis and ongoing protein in the urine (proteinuria). It has long been recognized that both the level and chronicity of proteinuria in patients with lupus nephritis are associated with disease severity and with long-term prognosis, including the possibility of progression to complete kidney failure, which may occur in about 1/4 of patients. Pentoxifylline (PTX) is an oral medication introduced 45 years ago for treatment of vascular insufficiency. It has also recently been found to reduce proteinuria in patients with diabetic nephropathy. The mechanism of this unexpected and intriguing finding is not certain, but may in part involve inhibiting the production of TNF-alpha, an inflammatory cytokine known to be present in urine and kidneys of patients with lupus nephritis. Our hypothesis is that this inexpensive, generic drug, PTX, can significantly reduce proteinuria in patients with lupus nephritis.
To test this hypothesis, we plan to initiate a 6-month, double-blind, placebo-controlled randomized clinical trial of PTX or placebo in 40 patients with active lupus nephritis. This trial will include 6-8 patients from each of 5 different academic medical centers that specialize in the treatment of lupus nephritis. Our primary objective of this trial will be to measure urine protein each month to determine the extent to which PTX is able to reduce urine protein, and how rapidly this occurs.
Read more
Concurrently, we will carefully follow these patients each month to determine whether PTX administration is also associated with stabilization of renal function, or with improvement in other manifestations of lupus, such as clinical disease activity or abnormal laboratory findings. A major secondary objective will be to explore the possible mechanism(s) whereby PTX reduces proteinuria. For this purpose, we will use the monthly urine specimens to measure TNF-alpha, and levels of several other proteins (IL-1, IL-6, IL-2, MCP-1, TGF-beta, PDGF, and IFN-alpha) that have been shown to contribute to inflammation and scarring in lupus nephritis. Comparison of levels of these inflammatory proteins with level of protein in the urine should help us to determine whether one or more of these proteins is a contributor to the severity or persistence of lupus nephritis.
This information may also allow us to learn whether repeated measurements of these proteins can serve as biomarkers to assist in the ongoing management of patients with lupus nephritis. Finally, we hope to eventually measure levels of these inflammatory proteins in blood samples from the patients, to determine if PTX treatment can suppress (or enhance) such levels, and whether these changes are associated with reduced lupus disease activity, or improvement in other manifestations of lupus. Ultimately, it is our hope that the data from this clinical trial using a generic repurposed drug will permit us to conclusively confirm that PTX can significantly reduce proteinuria in patients with lupus nephritis, which would be of great benefit for the thousands of people who suffer with this most severe type of lupus.
Read the detailed description
Glomerulonephritis occurs in up to one-half of patients with systemic lupus erythematosus (SLE) and is a major cause of morbidity and mortality. Guidelines published by the American College of Rheumatology in 2012 (1) suggested a multi-targeted treatment approach that has been shown to lead to clinical remission in up to one-half of patients (2,3).
However, at least one-third of patients continue to have active disease; many of these individuals may eventually develop renal failure. Therefore, there is an unmet need for more effective therapeutic approaches for lupus nephritis (LN). Although the pathogenesis of LN is almost certainly multifactorial, the presence and persistence of immune complexes are thought to play a major role in disease pathogenesis by attracting inflammatory cells of the innate immune system, such as neutrophils and monocytes, resulting in cell activation and secretion of inflammatory cytokines, including interferon alpha, TGF-beta, IL-1, IL-6, and TNF-alpha (6-7). Pentoxifylline (PTX) is a nonselective phosphodiesterase inhibitor with minimal toxicity. It has been in clinical use since 1972 for treatment of patients with intermittent claudication secondary to peripheral vascular disease. This generic drug has also recently been increasingly used off-label for several other conditions, including patients with diabetic nephropathy, in whom the unexpected finding of significant reduction of proteinuria has been repeatedly demonstrated (34-38). The mechanism of this phenomenon is unclear, although experimental studies in animals and humans have observed suppression of inflammatory cytokine production following PTX administration (24-28). In LN, 2 small, uncontrolled observational studies of PTX reported reduction in proteinuria following 2-6 months of treatment with PTX (8,9). The level and chronicity of proteinuria have long been associated with disease prognosis in patients with LN (10). Thus, a novel treatment that could significantly and persistently reduce or even eliminate proteinuria could result in substantial improvement in the long-term outcome of patients with this most serious manifestation of SLE.
- Conditions
- Lupus Nephritis
- Being tested
- Pentoxifylline, Placebos
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Also called Trental
Pentoxifylline (PTX) is a methylxanthine derivative that is a nonselective inhibitor of cyclic nucleotide phosphodiesterase (PDE). This enzyme, which has at least 5 subtypes, is responsible for inactivation of the important second messengers, Cyclic adenosine monophosphate (AMP) and cyclic guanosine monophosphate (GMP)
PlacebosDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline | Experimental | Pentoxifylline and standard of care therapy Receives: Drug: Pentoxifylline |
| Placebo | Placebo comparator | Placebo and standard of care therapy Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of proteinuria
Level of proteinuria measured as the protein/creatinine ratio on a morning first void specimen, recorded longitudinally at monthly intervals from baseline to 6 months, and from urine specimens provided monthly for 3 months following the 6 month study termination visit.
Measured: 9 months
Secondary outcomes (9)
Histopathologic subclass
The effect of Pentoxifylline on proteinuria relative to disease duration and histopathologic subclass.We will stratify these subjects in to 3 groups: class II, class III/IV, and class V. Given the relatively low expected frequency of class II (about 20%) and class V (about 10%), and the small total number of subjects, we will likely only be able to observe trends in responses of proteinuria to Pentoxifylline treatment in the 3 groups, without observing significant differences between groups.
Measured: 6 months
Serum albumin
Longitudinal changes in serum albumin over 6 months
Measured: 6 months
Glomerular Filtration Rate
Longitudinal changes in glomerular filtration rate (GFR)
Measured: 6 months
Serologic markers
Longitudinal changes in serologic markers including anti-DNA, complement component 3 (C3), and complement component 4(C4)
Measured: 6 months
SELENA-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Instrument Score
Longitudinal changes in SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) Instrument Score. This tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with Systemic Lupus Erythematosus.This assessment can be completed to objectively assess the patient's current state of disease. The descriptors with a weight of 8 are seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, and vasculitis. The descriptors with a weight of 4 are arthritis, myositis, urinary casts, hematuria, proteinuria, and pyuria. The descriptors with a weight of 2 are rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, and increased DNA binding. The descriptors with a weight of 1 are fever, thrombocytopenia, and leukopenia.
Measured: 6 months
Longitudinal changes in patient global activity score
This score measures the disease activity from the patient's perspective. It is measured from 0 to 10 with 10 being the worst.
Measured: 6 months
Longitudinal changes in physician global activity score
This score measures the disease activity from the physician's perspective.It is measured from 0 to 10 with 10 being the worst.
Measured: 6 months
Prednisone dose
Longitudinal changes in prednisone dose (and total cumulative prednisone dose)
Measured: 6 months
Serum and urinary cytokine levels
Correlation between serum and urinary cytokine levels (Tumor necrosis factor(TNF-alpha), Interleukin 1 (IL1), Interleukin 6 (IL6), Interleukin 2 (IL-2), Monocyte chemoattractant protein -1 (MCP-1), Transforming growth factor beta(TGF-beta), Interferon alpha (IFN-alpha), and Platelet-derived growth factor (PDGF) and changes in urinary protein excretion at baseline and at 1, 2, 3, and 6 months
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 posted1 Mar 2019
- Study start1 Sep 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Study not selected to receive funding
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, The Research Foundation for the State University of New York, Yale University
- Responsible party
- Principal investigator, Stanley Ballou, MetroHealth Medical Center
- Investigators
- Stanley Ballou, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859570
- Sponsor's protocol ID
- IRB18-00310
- Acronym
- Pentoxifylline
- Status last verified
- Jan 2021
- First submitted
- 22 Feb 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Randomized Trial of Pentoxifylline or Placebo in Addition to Standard of Care for Treatment of Proteinuria in Patients With Lupus Nephritis.
- ClinicalTrials.gov ID
- NCT03859570
- Acronym / sponsor ID
- Pentoxifylline / IRB18-00310
- Conditions
- Lupus Nephritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not selected to receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Ohio State University, The Research Foundation for the State University of New York, Yale University
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Mar 2019 (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.
Glomerulonephritis is an important manifestation in about 1/2 of patients with Systemic Lupus Nephritis (SLE; lupus). Despite recent national guidelines recommending use of induction therapy with high-dose corticosteroids and immunosuppressive agents, followed by prolonged maintenance therapy, up to 1/3 of these patients continue to have active nephritis and ongoing protein in the urine (proteinuria). It has long been recognized that both the level and chronicity of proteinuria in patients with lupus nephritis are associated with disease severity and with long-term prognosis, including the possibility of progression to complete kidney failure, which may occur in about 1/4 of patients. Pentoxifylline (PTX) is an oral medication introduced 45 years ago for treatment of vascular insufficiency. It has also recently been found to reduce proteinuria in patients with diabetic nephropathy. The mechanism of this unexpected and intriguing finding is not certain, but may in part involve inhibiting the production of TNF-alpha, an inflammatory cytokine known to be present in urine and kidneys of patients with lupus nephritis. Our hypothesis is that this inexpensive, generic drug, PTX, can significantly reduce proteinuria in patients with lupus nephritis.
To test this hypothesis, we plan to initiate a 6-month, double-blind, placebo-controlled randomized clinical trial of PTX or placebo in 40 patients with active lupus nephritis. This trial will include 6-8 patients from each of 5 different academic medical centers that specialize in the treatment of lupus nephritis. Our primary objective of this trial will be to measure urine protein each month to determine the extent to which PTX is able to reduce urine protein, and how rapidly this occurs.
Concurrently, we will carefully follow these patients each month to determine whether PTX administration is also associated with stabilization of renal function, or with improvement in other manifestations of lupus, such as clinical disease activity or abnormal laboratory findings. A major secondary objective will be to explore the possible mechanism(s) whereby PTX reduces proteinuria. For this purpose, we will use the monthly urine specimens to measure TNF-alpha, and levels of several other proteins (IL-1, IL-6, IL-2, MCP-1, TGF-beta, PDGF, and IFN-alpha) that have been shown to contribute to inflammation and scarring in lupus nephritis. Comparison of levels of these inflammatory proteins with level of protein in the urine should help us to determine whether one or more of these proteins is a contributor to the severity or persistence of lupus nephritis.
This information may also allow us to learn whether repeated measurements of these proteins can serve as biomarkers to assist in the ongoing management of patients with lupus nephritis. Finally, we hope to eventually measure levels of these inflammatory proteins in blood samples from the patients, to determine if PTX treatment can suppress (or enhance) such levels, and whether these changes are associated with reduced lupus disease activity, or improvement in other manifestations of lupus. Ultimately, it is our hope that the data from this clinical trial using a generic repurposed drug will permit us to conclusively confirm that PTX can significantly reduce proteinuria in patients with lupus nephritis, which would be of great benefit for the thousands of people who suffer with this most severe type of lupus.
Detailed description
Glomerulonephritis occurs in up to one-half of patients with systemic lupus erythematosus (SLE) and is a major cause of morbidity and mortality. Guidelines published by the American College of Rheumatology in 2012 (1) suggested a multi-targeted treatment approach that has been shown to lead to clinical remission in up to one-half of patients (2,3).
However, at least one-third of patients continue to have active disease; many of these individuals may eventually develop renal failure. Therefore, there is an unmet need for more effective therapeutic approaches for lupus nephritis (LN). Although the pathogenesis of LN is almost certainly multifactorial, the presence and persistence of immune complexes are thought to play a major role in disease pathogenesis by attracting inflammatory cells of the innate immune system, such as neutrophils and monocytes, resulting in cell activation and secretion of inflammatory cytokines, including interferon alpha, TGF-beta, IL-1, IL-6, and TNF-alpha (6-7). Pentoxifylline (PTX) is a nonselective phosphodiesterase inhibitor with minimal toxicity. It has been in clinical use since 1972 for treatment of patients with intermittent claudication secondary to peripheral vascular disease. This generic drug has also recently been increasingly used off-label for several other conditions, including patients with diabetic nephropathy, in whom the unexpected finding of significant reduction of proteinuria has been repeatedly demonstrated (34-38). The mechanism of this phenomenon is unclear, although experimental studies in animals and humans have observed suppression of inflammatory cytokine production following PTX administration (24-28). In LN, 2 small, uncontrolled observational studies of PTX reported reduction in proteinuria following 2-6 months of treatment with PTX (8,9). The level and chronicity of proteinuria have long been associated with disease prognosis in patients with LN (10). Thus, a novel treatment that could significantly and persistently reduce or even eliminate proteinuria could result in substantial improvement in the long-term outcome of patients with this most serious manifestation of SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline | Experimental | Drug: PentoxifyllinePentoxifylline and standard of care therapy |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo and standard of care therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients 18 and older, who meet the 1997 update of the1982 criteria for classification of systemic lupus erythematosus and have established lupus nephritis as documented by any of the following:
- Absence of changes in immunosuppressive agents or dose of immunosuppressive agents administered during the 2 months before enrollment. Patients with newly-diagnosed lupus nephritis will not be invited to participate until after they have completed 6 months of initial induction therapy.
- Unless contraindicated, patients will be required to be taking an ACE inhibitor or ARB, with stable dose for at least 1 month prior to enrollment. Patients with intolerance of ACE/ARB therapies will be eligible to participate, but will be analyzed separately, as indicated in the trial synopsis.
- Urine protein more than 500 mg/24 hours and/or UPCR more than 0.5 mg/mg at time of baseline.
- Willingness to remain on stable immunosuppressive drugs for the 6-month duration of the study unless safety issues arise.
Key exclusion criteria (16 listed)
- History of retinal, cerebral, or peptic ulcer hemorrhage within 3 months prior to enrollment
- Current use of warfarin, long-acting heparin, or an oral anti-coagulant (other than low dose aspirin)
- Pregnancy or currently breast-feeding
- History of theophylline, pentoxifylline, or caffeine allergy
- Currently taking theophylline-containing medications
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 |
|---|---|---|
| PentoxifyllineAlso: TrentalPentoxifylline (PTX) is a methylxanthine derivative that is a nonselective inhibitor of cyclic nucleotide phosphodiesterase (PDE). This enzyme, which has at least 5 subtypes, is responsible for inactivation of the important second messengers, Cyclic adenosine monophosphate (AMP) and cyclic guanosine monophosphate (GMP) | Drug | Pentoxifylline |
| PlacebosPlacebo | Drug | Placebo |
Primary outcome
Level of proteinuria
Time frame: 9 months
Level of proteinuria measured as the protein/creatinine ratio on a morning first void specimen, recorded longitudinally at monthly intervals from baseline to 6 months, and from urine specimens provided monthly for 3 months following the 6 month study termination visit.
9 secondary outcomes
Histopathologic subclass
Time frame: 6 months
Serum albumin
Time frame: 6 months
Glomerular Filtration Rate
Time frame: 6 months
Serologic markers
Time frame: 6 months
SELENA-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Instrument Score
Time frame: 6 months
Longitudinal changes in patient global activity score
Time frame: 6 months
Longitudinal changes in physician global activity score
Time frame: 6 months
Prednisone dose
Time frame: 6 months
Serum and urinary cytokine levels
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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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.
Stanley Ballou, MD principal investigator
MetroHealth Medical Center
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 Pentoxifylline in people with Lupus Nephritis, run by MetroHealth Medical Center at 1 site in United States.
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 10 inclusion and 16 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: withdrawn, as of the sponsor's last update on 2 Feb 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Level of proteinuria (time frame: 9 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 2 Feb 2021; AzTrials last refreshed its copy on 27 Oct 2026.