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Corticosteroid

Avacopan for Kidney Failure

Phase 1
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Group 1 (normal renal function): eGFR ≥90 mL/min and no history of renal disease.
Male or female participants, between 18 and 75 years of age (inclusive) at the time of Screening.
Must not have
History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration, or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome); or a history of gastrointestinal surgery, other than uncomplicated appendectomy.
Female participants with a positive pregnancy test at Screening or Check-in.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

"This trial aims to study how the drug avacopan and its breakdown product (M1) are processed in the body after a single dose in people with normal kidney function and in those with end

Who is the study for?
This trial is for adults aged 18-75 with either normal kidney function or end-stage renal disease requiring dialysis. Participants must have a body mass index between 18 and <40 kg/m^2, provide informed consent, and meet specific criteria for kidney function.
What is being tested?
The study aims to understand how the drug Avacopan behaves in the body after a single dose in people with normal kidneys compared to those with severe kidney failure on hemodialysis.
What are the potential side effects?
While not explicitly listed here, side effects of Avacopan may include headaches, nausea, high blood pressure, and potential allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is normal, with an eGFR of 90 or higher and no kidney disease history.
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I am between 18 and 75 years old.
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My kidney function is very low, and I am on dialysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of serious stomach or bowel problems, or I've had gastrointestinal surgery.
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I am not pregnant, as confirmed by a test.
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I currently have an active cancer.
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I do not have any uncontrolled major health issues.
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My liver function tests are within normal limits.
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My diabetes is not well-controlled, with an A1C level over 10%.
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I have a functioning organ transplant and/or am on immunosuppressants.
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I have no history of serious heart rhythm problems.
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I do not have normal kidney function.
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I have a history of kidney problems or abnormal kidney tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 3 trial • 331 Patients • NCT02994927
24%
Oedema peripheral
23%
Muscle spasms
22%
Arthralgia
21%
Anti-neutrophil cytoplasmic antibody positive vasculitis
21%
Nausea
18%
Hypertension
18%
Nasopharyngitis
16%
Cough
15%
Insomnia
15%
Diarrhoea
15%
Upper respiratory tract infection
14%
Headache
14%
Urinary tract infection
13%
Epistaxis
13%
Vomiting
13%
Myalgia
13%
Back pain
12%
Pyrexia
12%
Hypercholesterolaemia
11%
Anaemia
11%
Lymphopenia
10%
Weight increased
9%
Fatigue
9%
Leukopenia
8%
Pain in extremity
8%
Rash
7%
Dyspnoea
7%
Oropharyngeal pain
7%
Constipation
7%
Alopecia
7%
Pneumonia
7%
Sinusitis
6%
Increased tendency to bruise
6%
Dyspepsia
6%
Abdominal pain upper
6%
Pruritus
6%
Bronchitis
6%
Dizziness
6%
Tremor
5%
Blood creatinine increased
5%
Cushingoid
4%
Paraesthesia
2%
Hepatic enzyme increased
2%
Pulmonary embolism
1%
Hyperglycaemia
1%
Oedema
1%
Bacteraemia
1%
Infectious pleural effusion
1%
Subcutaneous abscess
1%
Hip fracture
1%
Benign prostatic hyperplasia
1%
Influenza
1%
Chronic kidney disease
1%
Episcleritis
1%
Glomerulonephritis
1%
Respiratory syncytial virus infection
1%
Aspartate aminotransferase increased
1%
Duodenitis
1%
Cryptococcosis
1%
Meningitis
1%
Staphylococcal infection
1%
Fungal infection
1%
Gastrointestinal disorder
1%
Renal impairment
1%
Sepsis
1%
Hypokalaemia
1%
Laryngeal stenosis
1%
Acute myocardial infarction
1%
Agranulocytosis
1%
Mononeuropathy multiplex
1%
Drug hypersensitivity
1%
Pulmonary alveolar haemorrhage
1%
Granulomatosis with polyangiitis
1%
Microscopic polyangiitis
1%
Thrombocytopenia
1%
Large intestine polyp
1%
Prostate cancer
1%
Neutropenia
1%
Abdominal pain
1%
Adrenal insufficiency
1%
Alanine aminotransferase increased
1%
Anxiety
1%
Aspergillus infection
1%
Asthenia
1%
Dehydration
1%
Acute kidney injury
1%
Granulomatous lymphadenitis
1%
Hernia
1%
Bone marrow failure
1%
Bone marrow toxicity
1%
Carcinoma in situ of skin
1%
Cerebral infarction
1%
Chondrocalcinosis pyrophosphate
1%
Coronary artery disease
1%
Death
1%
Deep vein thrombosis
1%
Herpes zoster
1%
Pneumonia bacterial
1%
Hyperkalaemia
1%
Hepatocellular injury
1%
Depression
1%
Device malfunction
1%
Enterocolitis
1%
Febrile neutropenia
1%
Osteonecrosis
1%
Interstitial lung disease
1%
Hypoaesthesia
1%
Lower respiratory tract infection
1%
Lumbar vertebral fracture
1%
Major depression
1%
Medical observation
1%
Lymphocyte count decreased
1%
Myocardial infarction
1%
Nasal ulcer
1%
Nervous system disorder
1%
Non-cardiac chest pain
1%
Ophthalmic herpes simplex
1%
Pulmonary arterial hypertension
1%
Purpura
1%
Rectal prolapse
1%
Parainfluenzae virus infection
1%
Pharyngeal ulceration
1%
Pneumomediastinum
1%
Pneumonia cytomegaloviral
1%
Post procedural haematoma
1%
Respiratory tract infection viral
1%
Small intestinal haemorrhage
1%
Somatic symptom disorder
1%
Systemic inflammatory response syndrome
1%
Transaminases increased
1%
Transitional cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prednisone Group
Avacopan Group

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2: ESRD Requiring HDExperimental Treatment1 Intervention
Participants in Group 2 will receive a single dose of avacopan on Day 1 in each of 2 treatment periods (Period 1/on HD and Period 2/off HD).
Group II: Group 1: Normal Renal FunctionExperimental Treatment1 Intervention
Participants in Group 1 will receive a single dose of avacopan on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avacopan
2018
Completed Phase 3
~940

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AmgenLead Sponsor
1,420 Previous Clinical Trials
1,382,938 Total Patients Enrolled
1 Trials studying Kidney Failure
3,352 Patients Enrolled for Kidney Failure
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,853 Total Patients Enrolled
~7 spots leftby Jan 2025
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