Anti-Glomerular Basement Membrane Antibody DiseasePhase 2GOOD-IDES-01NCT03157037
Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease
A Phase 2 study testing Imlifidase in people with Anti-Glomerular Basement Membrane Antibody Disease, run by Mårten Segelmark at 10 sites in 5 countries.
Trial summary
This study will evaluate the safety and tolerability of IdeS in patients with severe anti-glomerular basement membrane (anti-GBM) disease receiving standard of care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange (PLEX). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Glomerular Basement Membrane Antibody Disease
- What is being tested?
- Imlifidase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 16 Jun 2017to 24 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Anti-GBM antibodies detected by ELISA above a level that is considered toxic by the investigator using local laboratory. Patients double-positive for anti-GBM and anti-neutrophil cytoplasmic antibodies (ANCAs) may be entered in the trial, but only if their level of anti-GBM antibodies fulfil the criteria listed above.
- Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73 m^2 (by modification of diet in renal disease (MDRD) equation) or if the patient is non-responsive to standard treatment, and has lost >15 ml/min/1.73 m^2 after start of treatment
- Haematuria on dipstick and/or urinary sediment
- Male or female patients aged at least 18 years; Female patients of childbearing potential may participate if highly effective contraception is used during the study, according to Clinical Trials Facilitation and Coordination Group (CTFG) guidance [18], see also section 4.9 (pregnancy test should be performed before inclusion).
- Willing and able to give written Informed Consent and to comply with the requirements of the study protocol; and
- Judged to be otherwise healthy by the Investigator, based on medical history, physical examination, and clinical laboratory assessments. Patients with clinical laboratory values that are outside of normal limits (other than those specified in the Exclusion Criteria) and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance, may be entered into the study.
Who cannot join
- Anuria for more than 2 days (less than 200 ml during last 48 hours);
- Dialysis dependency for more than 5 days (maximum 3 sessions before signing informed consent);
- Ongoing moderate to severe pulmonary haemorrhage (or having ceased within the last two weeks), defined as requiring assisted ventilation, oxygen or blood transfusions.
- Pregnancy.
- Symptomatic congestive heart failure (NYHA class 2-4) and requiring prescription medication or clinically evident peripheral edema of cardiac origin;
- Myocardial infarction, unstable angina or stroke within 3 months prior to screening;
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- Ongoing bacterial infection requiring antibiotic therapy or viral infection with Hepatitis B, C or HIV (up to 3 months old negative test results are accepted); or active tuberculosis as indicated by chest x-ray.
- Patients should not have received investigational drugs within 30 days prior to screening or within 4 half-lives (whichever is longer); and
- History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
France5 sites
Department of Nephrology, Hemodialysis, Apheresis, and Transplantation, CHUGA (centre hospitalier universitaire Grenoble-Alpes)
Grenoble
Centre Hospitalier Régional Universitaire de Lille, Nephrology Service
Lille, 59000
PH USI UNTR, service du Pr Rondeau, Hôpital Tenon
Paris, Paris Cedex 20, 75020
Nephrology Service CHU Bichat
Paris, 75018
Department of Nephrology and Organ Transplant, CHU Rangueil
Toulouse, 31059
Sweden2 sites
Karolinska University Hospital Huddinge
Stockholm, 141 86
Department of Nephrology, Uppsala University Hospital
Uppsala, 75185
Austria1 site
Department of Internal Medicine IV (Nephrology and Hypertension)
Innsbruck, 6020
Czechia1 site
Department of Department of nephrology, First Faculty of Medicine and General Teaching Hospital and Charles University in Prague, Czech Republic,
Prague, 121 08
Denmark1 site
Department of Department of Nephrology, Rigshospitalet, Copenhagen
Copenhagen, 2100
About this study
Official title: Open-Label Phase II Study in Anti-GBM Disease (Goodpasture's Disease) With Adverse Renal Prognosis to Evaluate the Efficacy and Safety of IdeS - GOOD-IDES
This study will evaluate the safety and tolerability of IdeS in patients with severe anti-glomerular basement membrane (anti-GBM) disease receiving standard of care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange (PLEX).
Read the detailed description
This is an Open-Label Phase 2 Study to Evaluate the Efficacy and Safety of IdeS in anti-GBM disease (Goodpasture's disease, i.e. GP) with Adverse Renal Prognosis. The primary efficacy objective is to evaluate the efficacy of an IdeS based regimen to salvage independent renal function measured as no need for dialysis at 6 months after IdeS treatment. The primary safety objective of this study is to evaluate the safety and tolerability of IdeS in patients with severe anti-GBM disease on background of standard care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide (CYC) combined with plasma exchange (PLEX). The patients will be followed during 6 months according to the study visit plan.
- Being tested
- Imlifidase
- Medical subject headings
- Rapidly progressive glomerulonephritis with pulmonary hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImlifidaseBiological
Also called Immunoglobulin G-degrading enzyme of Streptococcus pyogenes, HMed-IdeS, IdeS
One dose of 0.25 mg/kg body weight imlifidase on study day 1
| Study group | Role | What they receive |
|---|---|---|
| Imlifidase | Experimental | Imlifidase 0.25 mg/kg body weight intravenous infusion Receives: Biological: Imlifidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Independent Renal Function at 6 Months
Number of patients without need for dialysis at 6 months. A patient with independent renal function is defined as a patient without need for dialysis.
Measured: 6 months after dosing
Secondary outcomes (15)
Number of Patients With Independent Renal Function at 3 Months
Number of patients without need for dialysis at 3 months. A patient with independent renal function is defined as a patient without need for dialysis.
Measured: 3 months after dosing
Renal Function at 3 and 6 Months
Estimated glomerular filtration rate (eGFR) is a measure of kidney function. eGFR was calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation.
eGFR for a kidney with normal function is above 90 mL/min/1.73m^2. Reduced kidney function is characterised by a decreased eGFR value.
Measured: 3 and 6 months after imlifidase dosing
Number of Patients With Renal Function Over Time Stratified by Ranges of eGFR
eGFR is a measure of kidney function. eGFR has been calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation.
eGFR for a kidney with normal function is above 90 mL/min/1.73m^2. Reduced kidney function is characterised by a decreased eGFR value.
Number of patients per 4 different eGFR categories (0-15, 15-30, 30-60, ≥60 mL/min/1.73m^2) are presented. A shift towards a higher category during the study indicates improved renal function over time.
Measured: Pre-imlifidase, 1, 3 and 6 months after imlifidase dosing
Number of Patients With Anti-GBM Antibodies Above a Toxic Level Stratified by Number of Study Visits
Anti-GBM antibodies above a toxic level defined as >20 U/mL. The level of anti-GBM antibodies was measured centrally using the Phadia ELiA(TM) anti-GBM kit. The enzyme-linked immunoassay (ELiA) is a fluorescence enzyme immunoassay.
Measured: Predose up to 6 months after dosing
Number of Patients With Haematuria (Blood in Urine)
Haematuria was assessed using urine dipstick. The result was presented as: Negative/Trace/+1/+2/+3/+4.
In the analysis results being +2 or above are considered as relevant. Haematuria was an inclusion criterion. All 15 patients had haematuria when included in the study.
Measured: At 6 months after dosing
Change in Proteinuria During the Study
Change in proteinuria measured as u-albumin/creatinine (g/mol) in morning void during the study .
Measured: Pre-imlifidase, 3 and 6 months after imlifidase dosing
Number of PLEXs Needed Over Time
Number of PLEXs needed before anti-GBM antibodies are below toxic levels. PLEX was initiated at the discretion of the investigator throughout the study.
Measured: Pre-screening and up to Day 93 after imlifidase dosing
Pharmacokinetics of Imlifidase (Cmax)
Maximum observed plasma concentration of IdeS following dosing (Cmax)
Measured: Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15
Pharmacokinetics of Imlifidase (AUC)
Area under the plasma concentration versus time curve (AUC)
Measured: Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15
Pharmacokinetics of Imlifidase (t1/2)
Half-life during distribution phase (Alpha-t1/2) Half-life during elimination phase (Beta-t1/2) The results refers to harmonic mean.
Measured: Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15
Pharmacokinetics of Imlifidase (CL)
Clearance (CL) is a measure of the ability of the body to clear imlifidase from plasma
Measured: Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15
Pharmacokinetics of Imlifidase (Vz)
Vz = Volume of distribution during the elimination phase
Measured: Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15
Pharmacodynamics (IgG Degradation Measured as Remaining Concentration of Intact and Single Cleaved IgG)
Imlifidase specifically cleaves all subclasses of human IgG rapidly and efficiently.
The cleaving process involves two steps: (i) intact IgG to single cleaved IgG followed by (ii) single cleaved IgG to completely cleaved IgG (one F(ab')2- and one homodimeric Fc-fragment) The electroluminescence analysis method used measures the sum of intact and single cleaved IgG in serum.
The efficacy of imlifidase is evaluated as remaining concentration of intact and single cleaved IgG in serum after treatment.
Measured: Pre-dose up to 6 months after imlifidase administration
Anti-imlifidase Antibodies (ADA)
Determination of anti-imlifidase antibody concentration
Measured: Up to 6 months after dosing
Renal Histology
Kidney biopsies were classified according to the histopathologic classification for antineutrophil cytoplasmic antibodies (ANCA)-associated glomerulonephritis developed by Berden et al. 2010.
This classification has previously been applied in a study of 123 anti-GBM disease patients (von Daalen et al 2018).
Histopathologic class:
- Focal (≤50% normal glomeruli)
- Crescentic (≥50% glomeruli with cellular crescents)
- Mixed (<50% normal, <50%crescentic, <50% globally sclerotic glomeruli)
- Sclerotic (≥50% globally sclerotic glomeruli) In addition information on the histological activity and kidney outcome was provided.
Focal class is associated with favourable kidney outcome, whereas sclerotic carries a poor outcome. Crescentic/mixed class could have an intermediate outcome between focal and sclerotic.
Immunofluorescence performed at the local hospitals was also used to assess linear IgG deposits which is a hallmark of anti-GBM antibody disease.
Measured: Before administration of imlifidase (0-33 days) and after administration of imlifidase (3-6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start16 Jun 2017
- Primary completion24 Jul 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anti-Glomerular Basement Membrane Antibody DiseaseStudies 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
- Model description
- Open-Label, Single Arm study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mårten Segelmark
- Sponsor type
- Other government
- Collaborators
- Hansa Biopharma AB
- Responsible party
- Sponsor-investigator, Mårten Segelmark, Linkoeping University
- Investigators
- Mårten Segelmark, MD PhD Prof, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157037
- Sponsor's protocol ID
- GOOD-IDES-01
- Acronym
- GOOD-IDES-01
- Status last verified
- Feb 2022
- First submitted
- 11 May 2017
- Last updated
- 7 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berden AE, Ferrario F, Hagen EC, Jayne DR, Jennette JC, Joh K, Neumann I, Noel LH, Pusey CD, Waldherr R, Bruijn JA, Bajema IM. Histopathologic classification of ANCA-associated glomerulonephritis. J Am Soc Nephrol. 2010 Oct;21(10):1628-36. doi: 10.1681/ASN.2010050477. Epub 2010 Jul 8.
PubMed 20616173van Daalen EE, Jennette JC, McAdoo SP, Pusey CD, Alba MA, Poulton CJ, Wolterbeek R, Nguyen TQ, Goldschmeding R, Alchi B, Griffiths M, de Zoysa JR, Vincent B, Bruijn JA, Bajema IM. Predicting Outcome in Patients with Anti-GBM Glomerulonephritis. Clin J Am Soc Nephrol. 2018 Jan 6;13(1):63-72. doi: 10.2215/CJN.04290417. Epub 2017 Nov 21.
PubMed 29162595Tyrberg L, Andersson F, Uhlin F, Hellmark T, Segelmark M. Using imlifidase to elucidate the characteristics and importance of anti-GBM antibodies produced after start of treatment. Nephrol Dial Transplant. 2023 Dec 20;39(1):45-54. doi: 10.1093/ndt/gfad132.
PubMed 37385828
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Phase II Study in Anti-GBM Disease (Goodpasture's Disease) With Adverse Renal Prognosis to Evaluate the Efficacy and Safety of IdeS - GOOD-IDES
- ClinicalTrials.gov ID
- NCT03157037
- Acronym / sponsor ID
- GOOD-IDES-01 / GOOD-IDES-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mårten SegelmarkOther government
- Collaborators
- Hansa Biopharma AB
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Posted 7 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and tolerability of IdeS in patients with severe anti-glomerular basement membrane (anti-GBM) disease receiving standard of care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange (PLEX).
Detailed description
This is an Open-Label Phase 2 Study to Evaluate the Efficacy and Safety of IdeS in anti-GBM disease (Goodpasture's disease, i.e. GP) with Adverse Renal Prognosis. The primary efficacy objective is to evaluate the efficacy of an IdeS based regimen to salvage independent renal function measured as no need for dialysis at 6 months after IdeS treatment. The primary safety objective of this study is to evaluate the safety and tolerability of IdeS in patients with severe anti-GBM disease on background of standard care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide (CYC) combined with plasma exchange (PLEX). The patients will be followed during 6 months according to the study visit plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label, Single Arm study
| Arm | Type | Receives |
|---|---|---|
| Imlifidase | Experimental | Biological: ImlifidaseImlifidase 0.25 mg/kg body weight intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Anti-GBM antibodies detected by ELISA above a level that is considered toxic by the investigator using local laboratory. Patients double-positive for anti-GBM and anti-neutrophil cytoplasmic antibodies (ANCAs) may be entered in the trial, but only if their level of anti-GBM antibodies fulfil the criteria listed above.
- Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73 m^2 (by modification of diet in renal disease (MDRD) equation) or if the patient is non-responsive to standard treatment, and has lost >15 ml/min/1.73 m^2 after start of treatment
- Haematuria on dipstick and/or urinary sediment
- Male or female patients aged at least 18 years; Female patients of childbearing potential may participate if highly effective contraception is used during the study, according to Clinical Trials Facilitation and Coordination Group (CTFG) guidance [18], see also section 4.9 (pregnancy test should be performed before inclusion).
- Willing and able to give written Informed Consent and to comply with the requirements of the study protocol; and
Key exclusion criteria (9 listed)
- Anuria for more than 2 days (less than 200 ml during last 48 hours);
- Dialysis dependency for more than 5 days (maximum 3 sessions before signing informed consent);
- Ongoing moderate to severe pulmonary haemorrhage (or having ceased within the last two weeks), defined as requiring assisted ventilation, oxygen or blood transfusions.
- Pregnancy.
- Symptomatic congestive heart failure (NYHA class 2-4) and requiring prescription medication or clinically evident peripheral edema of cardiac origin;
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 |
|---|---|---|
| ImlifidaseAlso: Immunoglobulin G-degrading enzyme of Streptococcus pyogenes, HMed-IdeS, IdeSOne dose of 0.25 mg/kg body weight imlifidase on study day 1 | Biological | Imlifidase |
Primary outcome
Number of Patients With Independent Renal Function at 6 Months
Time frame: 6 months after dosing
Number of patients without need for dialysis at 6 months. A patient with independent renal function is defined as a patient without need for dialysis.
15 secondary outcomes
Number of Patients With Independent Renal Function at 3 Months
Time frame: 3 months after dosing
Renal Function at 3 and 6 Months
Time frame: 3 and 6 months after imlifidase dosing
Number of Patients With Renal Function Over Time Stratified by Ranges of eGFR
Time frame: Pre-imlifidase, 1, 3 and 6 months after imlifidase dosing
Number of Patients With Anti-GBM Antibodies Above a Toxic Level Stratified by Number of Study Visits
Time frame: Predose up to 6 months after dosing
Number of Patients With Haematuria (Blood in Urine)
Time frame: At 6 months after dosing
Change in Proteinuria During the Study
Time frame: Pre-imlifidase, 3 and 6 months after imlifidase dosing
Number of PLEXs Needed Over Time
Time frame: Pre-screening and up to Day 93 after imlifidase dosing
Pharmacokinetics of Imlifidase (Cmax)
Time frame: Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15
Pharmacokinetics of Imlifidase (AUC)
Time frame: Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15
Pharmacokinetics of Imlifidase (t1/2)
Time frame: Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15
Pharmacokinetics of Imlifidase (CL)
Time frame: Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15
Pharmacokinetics of Imlifidase (Vz)
Time frame: Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15
Pharmacodynamics (IgG Degradation Measured as Remaining Concentration of Intact and Single Cleaved IgG)
Time frame: Pre-dose up to 6 months after imlifidase administration
Anti-imlifidase Antibodies (ADA)
Time frame: Up to 6 months after dosing
Renal Histology
Time frame: Before administration of imlifidase (0-33 days) and after administration of imlifidase (3-6 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20616173Berden AE, Ferrario F, Hagen EC, Jayne DR, Jennette JC, Joh K, Neumann I, Noel LH, Pusey CD, Waldherr R, Bruijn JA, Bajema IM. Histopathologic classification of ANCA-associated glomerulonephritis. J Am Soc Nephrol. 2010 Oct;21(10):1628-36. doi: 10.1681/ASN.2010050477. Epub 2010 Jul 8.
- Background: PubMed 29162595van Daalen EE, Jennette JC, McAdoo SP, Pusey CD, Alba MA, Poulton CJ, Wolterbeek R, Nguyen TQ, Goldschmeding R, Alchi B, Griffiths M, de Zoysa JR, Vincent B, Bruijn JA, Bajema IM. Predicting Outcome in Patients with Anti-GBM Glomerulonephritis. Clin J Am Soc Nephrol. 2018 Jan 6;13(1):63-72. doi: 10.2215/CJN.04290417. Epub 2017 Nov 21.
- Derived from this study: PubMed 37385828Tyrberg L, Andersson F, Uhlin F, Hellmark T, Segelmark M. Using imlifidase to elucidate the characteristics and importance of anti-GBM antibodies produced after start of treatment. Nephrol Dial Transplant. 2023 Dec 20;39(1):45-54. doi: 10.1093/ndt/gfad132.
- 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.
Mårten Segelmark, MD PhD Prof principal investigator
Linkoeping University
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imlifidase in people with Anti-Glomerular Basement Membrane Antibody Disease, run by Mårten Segelmark at 10 sites in 5 countries.
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 9 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Sweden, Austria, Czechia, Denmark. 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?
Yes. Results are posted in the registry (first posted 7 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Independent Renal Function at 6 Months (time frame: 6 months after dosing). 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 NCT03157037, which also lists 3 linked publications.
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 7 Apr 2022.