Pegcetacoplan for Kidney Transplant

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Kidney Transplant+8 MorePegcetacoplan - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test a new drug to see if it is safe and effective in treating people who have had a kidney transplant and whose disease has returned.

Eligible Conditions
  • Complement 3 Glomerulopathy
  • Kidney Transplant
  • Membranoproliferative Glomerulonephritis
  • Complement 3 Glomerulonephritis
  • Dense Deposit Disease
  • IgA Nephropathy (IgAN) or Immunoglobulin A Nephropathy (IgA Nephropathy)
  • Immune Complex Membranoproliferative Glomerulonephritis
  • C3 Glomerulonephritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 11 Secondary · Reporting Duration: 12 weeks after randomization

12 weeks after enrollment
The primary efficacy endpoint is the proportion of patients with reduction in C3c staining on renal biopsy after 12 weeks of treatment with pegcetacoplan.
12 weeks after randomization
The primary efficacy endpoint is the proportion of subjects with reduction in C3c staining on renal biopsy after 12 weeks of treatment with pegcetacoplan.
The proportion of subjects achieving complete clinical remission of proteinuria
52 weeks after enrollment
The number and incidence of treatment-related adverse events (AEs)
The proportion of patients achieving at least a 50% reduction in proteinuria, over time
The proportion of patients achieving complete clinical remission of proteinuria, defined as normalization of proteinuria
The proportion of patients with reduction in C3c staining on renal biopsy
The proportion of patients with stabilization or improvement in estimated glomerular filtration rate (eGFR), over time
52 weeks after randomization
The number and incidence of treatment-emergent adverse events (TEAEs)
The proportion of subjects achieving at least a 50% reduction in proteinuria
The proportion of subjects with reduction in C3c staining on renal biopsy
The proportion of subjects with stabilization or improvement in estimated glomerular filtration rate (eGFR)
The proportion of subjects with stabilization or improvement of serum creatinine concentration

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Side Effects for

Open-label Period: Pegcetacoplan
17%Haemolysis
16%Nasopharyngitis
14%Diarrhoea
12%Injection site erythema
12%Cough
10%Fatigue
10%Headache
9%Urinary tract infection
9%Upper respiratory tract infection
8%Arthralgia
8%Oral herpes
8%Pyrexia
8%Oropharyngeal pain
6%Injection site pruritus
6%Injection site induration
6%Pain in extremity
5%Contusion
5%Abdominal distension
5%Myalgia
5%Anxiety
5%Injection site pain
5%Acute kidney injury
5%Asthenia
4%Abdominal pain
4%Vomiting
4%Sinusitis
4%Injection site bruising
4%Hypertension
4%Hyperbilirubinaemia
4%Dizziness
4%Thrombocytopenia
4%Erythema
3%Injection site reaction
3%Anaemia
3%Constipation
3%Vaccination complication
3%Dyspnoea
3%Decreased appetite
3%Nausea
3%Gastroenteritis
3%Back pain
3%Chromaturia
1%Ovarian cyst
1%Hypersensitivity pneumonitis
1%Haemolytic anaemia
1%Post procedural sepsis
1%Sepsis
1%Diverticulitis
1%Haemoglobinuria
1%Cholelithiasis
1%Epistaxis
1%Biliary sepsis
1%Oedematous pancreatitis
1%Injection site swelling
1%Deep vein thrombosis
1%Diffuse large B-cell lymphoma
1%Intestinal ischaemia
1%Acute myeloid leukaemia
1%Allergy to immunoglobulin therapy
1%Cytopenia
1%COVID-19
1%Small intestinal obstruction
1%Haematoma muscle
1%Insomnia
1%Palpitations
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT03500549) in the Open-label Period: Pegcetacoplan ARM group. Side effects include: Haemolysis with 17%, Nasopharyngitis with 16%, Diarrhoea with 14%, Injection site erythema with 12%, Cough with 12%.

Trial Design

1 Treatment Group

Group 1
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Pegcetacoplan · No Placebo Group · Phase 2

Group 1
Drug
Experimental Group · 1 Intervention: Pegcetacoplan · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegcetacoplan
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks after randomization

Who is running the clinical trial?

Apellis Pharmaceuticals, Inc.Lead Sponsor
21 Previous Clinical Trials
3,504 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have clinical and pathologic evidence of recurrent C3G or IC-MPGN.
You are at least 18 years of age.
References

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