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Tests treatment safety and results for Berger Disease
Official title Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
ClinicalTrials.gov ID: NCT07498335
What this study is testing
What is Drug: Atrasentan?
Drug: Atrasentan is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for berger disease.
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
- A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to \<18 years with primary immunoglobulin A nephropathy (IgAN).
- Phase 3: a large, late-stage study
- Time commitment: about 104 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- Signed informed consent by parent(s)/legal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed...
- Male and female participants 2 to \< 18 years of age as of Day 1.
- eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.
- Kidney biopsy-proven primary IgAN\ , with biopsy performed within 3 years of Screening with \< 50% tubulointerstitial fibrosis and \< 25% crescents...
- Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g/g (113 mg/mmoL) sampled from FMV at Screening on Day -90 and Day -60 as well...
You likely can't join if
- Participation in any other investigational drug trial or use of other investigational drugs at the time of enrollment, or within 5 elimination...
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
- Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus...
- A clinical diagnosis of IgA vasculitis (IgAV or Henoch-Schoenlein purpura) based on typical palpable purpura with or without arthralgia and abdominal...
- Evidence of significant urinary obstruction or difficulty in voiding, any urinary tract disorder causing significant urinary obstruction or...
- Concurrent diagnosis of CKD other than IgAN at Screening and before first study drug administration.
See the full eligibility criteria
Who can join
- Signed informed consent by parent(s)/legal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed. A consent or assent may also be required for some participants...
- Male and female participants 2 to \< 18 years of age as of Day 1.
- eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.
- Kidney biopsy-proven primary IgAN\ , with biopsy performed within 3 years of Screening with \< 50% tubulointerstitial fibrosis and \< 25% crescents. In case a kidney biopsy within 3 years from Screening is not...
- Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g/g (113 mg/mmoL) sampled from FMV at Screening on Day -90 and Day -60 as well as during the Run-in Period despite treatment with maximum tolerated...
- All participants must have been on supportive care including stable dose regimen of ACE inhibitor or ARB at either the locally approved maximal daily dose per body weight, or the maximally tolerated dose (per...
- The minimum body weight of enrolled pediatric participants is 10 kg at Screening and confirmed on Day 1.
- Parent(s)/guardian(s) are to be able to communicate well with the investigator and to understand and comply with the study's requirements for their child.
What rules you out
- Participation in any other investigational drug trial or use of other investigational drugs at the time of enrollment, or within 5 elimination half-lives of enrollment, or within 30 days of enrollment, whichever is...
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
- Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, Herpes Simplex virus infection, dermatitis herpetiformis...
- A clinical diagnosis of IgA vasculitis (IgAV or Henoch-Schoenlein purpura) based on typical palpable purpura with or without arthralgia and abdominal pain.
- Evidence of significant urinary obstruction or difficulty in voiding, any urinary tract disorder causing significant urinary obstruction or difficulty in voiding at Screening and confirmed at Baseline/Day 1.
- Concurrent diagnosis of CKD other than IgAN at Screening and before first study drug administration.
- Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of Screening.
- Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to Screening or during Screening and Run-in periods.
- Presence of nephrotic syndrome at Screening based on the investigator's judgement.
- BNP value of \>200 pg/mL at Screening.
- Hemoglobin below 9 g/dL at Screening or prior history of blood transfusion for anemia within 3 months of Screening.
- Platelet count \<80,000/μL at Screening.
- On Day 1 participants' body weight falls below the lower limit of the cohort in which the participant was initially screened and lower body weight cohort is not open for enrollment.
- Known history of congenital heart disease, heart failure or clinically significant fluid retention such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites before treatment.
- Current use of any homeopathic and/or herbal medications for the treatment of IgAN disease , such as but not limited to Tripterygium wilfordii (Lei Gong Teng), Caulis sinomenii and Sinomenium acutum before treatment.
- History of an alcohol or illicit drug-related disorder within the past 3 years at Screening.
- Confirmed blood pressure \>150 mmHg systolic or \>95 mmHg diastolic for 12 to \ 140 mmHg systolic or \>90 mmHg diastolic for 6 to \ 120 mmHg systolic or \>80 mmHg diastolic for 2 to \<6 years of age; based on the mean...
- Participants previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate...
- History of organ transplantation (people with history of corneal transplant are not excluded) before treatment.
- Major concurrent comorbidities before treatment including but not limited to advanced cardiac disease (e.g., NYHA class III (for ages 6 to \<18 years), Ross class III (for ages 2 to \<6years)), severe pulmonary disease...
- Any medical condition deemed likely to interfere with the subject's participation in the study before treatment.
- Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.
- Presence of fever ≥ 38°C (100.4°F) within 7 days prior to study drug administration.
- Human immunodeficiency virus (HIV) infection (known history of HIV or test positive for HIV antibody at Screening).
- Liver disease, such as active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as Hepatitis B surface antigen (HBsAg) positive or Hepatitis C virus ribonucleic acid (HCV-RNA) positive at Screening...
- Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3X upper limit of normal (ULN)
- Serum bilirubin must not exceed 2X ULN
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer treated with curative intent), treated or untreated, within the past 5 years, regardless of...
- Pregnant or nursing (lactating) female participants (of childbearing potential), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human...
- people taking prohibited therapies before treatment.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure...
- Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not...
- Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of...
- Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks before taking study treatment).
- Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to screening provided partner(s) has(have) received medical confirmation of surgical success.
- Use of hormonal contraception methods:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal.
- Progestogen-only hormonal contraception (where inhibition of ovulation is not the primary or only mode of action): oral, injectable or implantable.
- Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study...
- All fertile male participants in a sexual relationship with a WOCBP must agree to the use of a condom during the trial and for up to one month after last study drug administration. A male participant is considered...
The study team makes the final eligibility decision.
Where it's taking place
- Neptune City, New Jersey, United States
- Cincinnati, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Memphis, Tennessee, United States
- Nagoya, Aichi-ken, Japan
- Fukuoka, Japan
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 - confirm specifics with the study team.
How long does this study last?
The study runs about 104 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Neptune City, New Jersey, United States; Cincinnati, Ohio, United States; Oklahoma City, Oklahoma, United States; Memphis, Tennessee, United States; Nagoya, Aichi-ken, Japan; Fukuoka, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.