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Complement Inhibitor

Pegcetacoplan for Glomerulonephritis (VALIANT Trial)

Phase 3
Waitlist Available
Research Sponsored by Apellis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No more than 50% global glomerulosclerosis or interstitial fibrosis on the baseline biopsy for adult participants or adolescent participants providing a baseline biopsy.
A diagnosis of primary C3G or IC-MPGN (with or without previous renal transplant).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 26
Awards & highlights

VALIANT Trial Summary

This trial will test if pegcetacoplan can help reduce proteinuria in patients with C3G or IC-MPGN.

Who is the study for?
Adults and certain adolescents with primary C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis, who have significant protein in their urine, stable kidney disease treatment regimens, and specific signs of active renal disease. Excludes those previously treated with Pegcetacoplan, secondary conditions causing the disease, severe infections or immune deficiencies, weight over 100 kg, known allergies to study drug components.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Pegcetacoplan versus a placebo in reducing proteinuria (excess protein in urine) for patients with C3G or IC-MPGN. Participants will receive twice-weekly subcutaneous doses and be monitored for changes in their condition.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression by Pegcetacoplan, allergic responses to medication ingredients, and possibly other unknown risks that are common when testing new treatments.

VALIANT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney biopsy shows less than 50% damage.
Select...
I have been diagnosed with primary C3G or IC-MPGN.
Select...
I have active kidney disease confirmed by tests or a biopsy.
Select...
I have active kidney disease confirmed by specific tests.
Select...
My kidney function is sufficient according to specific medical calculations.

VALIANT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The log-transformed ratio of uPCR at week 26 compared to baseline
Secondary outcome measures
Change from baseline in eGFR
For participants with evaluable renal biopsies, the change from baseline in the activity score of the C3G histologic index score
The proportion of participants who meet the criteria for achieving a composite renal endpoint (a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and a ≥50% reduction in uPCR compared to the baseline visit.)
+2 more

Side effects data

From 2020 Phase 3 trial • 80 Patients • NCT03500549
41%
Injection site erythema
15%
Injection site pruritus
13%
Headache
13%
Injection site swelling
13%
Diarrhoea
10%
Injection site reaction
9%
Nausea
8%
Pyrexia
8%
Injection site pain
6%
Fatigue
6%
Injection site induration
5%
Dyspnoea
5%
Nasopharyngitis
4%
Contusion
4%
Dizziness
4%
Chromaturia
4%
Vaccination site pain
4%
Pain in extremity
4%
Back pain
4%
Myalgia
3%
Vaccination complication
3%
Anxiety
3%
Thrombocytopenia
3%
Cough
3%
Abdominal pain
3%
Abdominal discomfort
3%
Arthralgia
3%
Injection site bruising
3%
Sepsis
1%
Haemolysis
1%
Vomiting
1%
Sinusitis
1%
Oral herpes
1%
Anaemia
1%
Asthenia
1%
Palpitations
1%
Abdominal distension
1%
Constipation
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Run-in Period: Pegcetacoplan + Eculizumab
Open-label Period: Pegcetacoplan
RCP: Eculizumab
RCP: Pegcetacoplan

VALIANT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1: Pegcetacoplan administrationExperimental Treatment1 Intervention
Subcutaneous infusion of 20mL (1080 mg), twice weekly (for adults or adolescents >50kg), and the three other weight-based doses either of 10mL (540mg), 12mL (648mg), or 15mL (810mg)
Group II: Group 2: Placebo administrationPlacebo Group1 Intervention
Subcutaneous infusion of either 10mL, 12mL, 15mL, or 20mL, twice weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegcetacoplan
2015
Completed Phase 3
~380

Find a Location

Who is running the clinical trial?

Apellis Pharmaceuticals, Inc.Lead Sponsor
24 Previous Clinical Trials
3,935 Total Patients Enrolled
4 Trials studying Glomerulonephritis
134 Patients Enrolled for Glomerulonephritis

Media Library

Glomerulonephritis Research Study Groups: Group 1: Pegcetacoplan administration, Group 2: Placebo administration

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been any previous testing of Pegcetacoplan on humans?

"Pegcetacoplan was first studied in 2018 at the HealthONE Physician Care. So far, there have been a total of 18297 completed clinical trials worldwide. Out of these active studies, 11 are being conducted presently with many taking place in Iowa City, Iowa."

Answered by AI

Could you please tell me how many hospitals are administering this trial?

"To make the trial more accessible to a larger pool of patients, it is being run out of 9 sites which are located in various cities including Iowa City, Los Angeles and Birmingham. If you enroll in the trial, try to select a location nearest you to cut down on travel time."

Answered by AI

What is the cap on recruitment for this research project?

"In order for this study to occur, 90 patients that meet the eligibility requirements must be recruited. The sponsor, Apellis Pharmaceuticals, Inc., will source participants from multiple locations including The University of Iowa in Iowa City, Iowa and Academic Medical Research Institute in Los Angeles."

Answered by AI

Are there any life-threatening risks associated with taking Pegcetacoplan?

"Pegcetacoplan has undergone Phase 3 clinical trials, meaning that there is both data supporting its efficacy and multiple rounds of data affirming its safety. Consequently, our team at Power rates Pegcetacoplan's safety as a 3."

Answered by AI

To your knowledge, does a similar study exist?

"Since 2018, Pegcetacoplan has undergone extensive clinical research. The first study was sponsored by Apellis Pharmaceuticals and included only 21 participants. Following this initial testing, Phase 2 drug approval was received in 2018. Currently, there are 11 active trials for Pegcetacoplan being conducted in 164 cities and 26 countries around the world."

Answered by AI

Are we currently enrolling people for this research project?

"The information on clinicialtrials.gov does show that this trial is looking for new patients at the moment. This particular clinical trial was created on November 12th, 2021 and updated most recently on August 4th, 2022. They are trying to recruit 90 people total from 9 locations."

Answered by AI

Who else is applying?

What state do they live in?
New York
California
What site did they apply to?
UCI Center for Clinical Research
Children's Hospital Colorado
CUIMC - Columbia Nephrology
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

Diclofenac for 3 yrs...many herbal & essential oils...curamin,joint products, anti inflammation homeopathic supplements...
PatientReceived no prior treatments
I've tried steroid injections, physical therapy and other modalities that weren't long term & don't want to constantly be taking alieve or other pain meds.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Cohen Children Hospital: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
2021. "Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05067127.
All > Degenerative Disc Disease
~3 spots leftby Jun 2024
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