Recruiting at 6 sites Phase 2 Immunoglobulin A Nephropathy

Immunoglobulin A Nephropathy study: Sparsentan

Official title A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy

ClinicalTrials.gov ID: NCT04663204

What this study is testing

What is Sparsentan?

An investigational oral medication being studied for the treatment of immunoglobulin A nephropathy (IgAN).

Also referred to as RE-021.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study aims to see if sparsentan can protect the kidneys in patients newly diagnosed with IgA nephropathy who have not used ACEI or ARB drugs, and in patients who have had a kidney transplant and then developed recurrent IgA nephropathy.
Who it's for
The study looks for adults newly diagnosed with IgA nephropathy who have not taken ACEI or ARB medications, and adults who have had a kidney transplant and now have recurrent IgA nephropathy.
What's involved
Participants will receive the drug sparsentan and will attend scheduled clinic visits for medical assessments and laboratory tests to monitor kidney function and safety.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • For Cohort A (Patients with Incident IgAN)
  • 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...

You likely can't join if

  • 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...
  • 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.
See the full eligibility criteria
Who can join
  • For Cohort A (Patients with Incident IgAN)
  • 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.
  • 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...
What rules you out
  • 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.
  • 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...
  • 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...
  • 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...
  • 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...
  • 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.
  • 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.
  • 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 \ 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...

The study team makes the final eligibility decision.

Where it is enrolling

  • Cambridge, England, United Kingdom
  • Salford, England, United Kingdom
  • Edinburgh, Scotland, United Kingdom
  • Cardiff, Wales, United Kingdom
  • Leicester, United Kingdom
  • London, United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Cambridge, England, United Kingdom; Salford, England, United Kingdom; Edinburgh, Scotland, United Kingdom; Cardiff, Wales, United Kingdom; Leicester, United Kingdom; London, United Kingdom. Enter your location above to see the nearest enrolling site and check your eligibility.

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BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.