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Chemokine Receptor Antagonist

Sequential for Focal Segmental Glomerulosclerosis

Phase 2
Waitlist Available
Research Sponsored by ChemoCentryx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects aged 18 years and older
Primary FSGS based on renal biopsy findings consistent with FSGS and based on presentation of histopathology, medical history and clinical course OR subjects with genetic risk factors with presentations that are otherwise consistent with primary FSGS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12 and week 52
Awards & highlights

Study Summary

This study is evaluating whether a drug called CCX140 may help treat people with a disease called FSGS.

Eligible Conditions
  • Focal Segmental Glomerulosclerosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 and week 52 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 Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20%
Secondary outcome measures
Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment
Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period
Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time
+10 more
Other outcome measures
Electrocardiography
Changes from baseline in blood pressure

Side effects data

From 2020 Phase 2 trial • 46 Patients • NCT03536754
18%
Upper respiratory tract infection
18%
Oedema peripheral
18%
Muscle spasms
18%
Gout
9%
Dental caries
9%
Blood creatine phosphokinase increased
9%
Proteinuria
9%
Oedema
9%
Asthenia
9%
Hyperkalaemia
9%
Arthralgia
9%
Hyperlipidaemia
9%
Tachycardia
9%
Nausea
9%
Diarrhoea
9%
Chest pain
9%
Sinusitis
9%
Fatigue
9%
Intervertebral disc degeneration
9%
Myopathy
9%
Blood creatinine increased
9%
Cough
9%
Productive cough
9%
Skin lesion
9%
Hypertension
9%
Insomnia
9%
Squamous cell carcinoma of skin
9%
Vitamin D deficiency
9%
Vomiting
9%
Conjunctivitis
9%
Blood potassium increased
9%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
CCX140-B 15 mg
Placebo Open Label
CCX140-B 10 mg
CCX140-B 15mg Open Label
Placebo
CCX140-B 5mg Open Label
CCX140-B 5 mg
CCX140-B 10mg Open Label

Trial Design

1Treatment groups
Experimental Treatment
Group I: SequentialExperimental Treatment1 Intervention
All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CCX-140
Not yet FDA approved

Find a Location

Who is running the clinical trial?

ChemoCentryxLead Sponsor
17 Previous Clinical Trials
2,335 Total Patients Enrolled
Peter Staehr, M.D.Study DirectorChemoCentryx

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome
2018. "A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03703908.
~1 spots leftby Apr 2025
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