Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03536754




Registration number
NCT03536754
Ethics application status
Date submitted
28/03/2018
Date registered
25/05/2018
Date last updated
5/12/2023

Titles & IDs
Public title
A Study of CCX140-B in Subjects With FSGS
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)
Secondary ID [1] 0 0
LUMINA-1
Secondary ID [2] 0 0
CL011_140
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
FSGS 0 0
Focal Segmental Glomerulosclerosis 0 0
Glomerulosclerosis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Placebo
Treatment: Drugs - CCX140-B
Treatment: Drugs - CCX140-B
Treatment: Drugs - CCX140-B

Placebo comparator: Group A - Placebo (N=10)

Experimental: Group B - CCX140-B 5 mg once daily (N=10)

Experimental: Group C - CCX140-B 10 mg twice daily (N=10)

Experimental: Group D - CCX140-B 15 mg twice daily (N=10)


Other interventions: Placebo
Three placebo tablets, taken twice daily (BID), per os, for 84 days (12 weeks)

Treatment: Drugs: CCX140-B
One 5 mg CCX140-B tablet and 2 placebo tablets in the morning; 3 placebo tablets in the evening; per os, for 84 days.

Treatment: Drugs: CCX140-B
Two 5 mg CCX140-B tablets and 1 placebo tablet, taken BID; per os, for 84 days.

Treatment: Drugs: CCX140-B
Three 5 mg CCX140-B tablets, taken BID; per os, for 84 days.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in UPCR at Week 12
Timepoint [1] 0 0
Baseline to Week 12
Primary outcome [2] 0 0
Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Baseline to Week 12, and Week 12 to Week 24
Primary outcome [3] 0 0
Change From Baseline in Activated Partial Thromboplastin Time
Timepoint [3] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [4] 0 0
Change From Baseline in Plasma Alanine Aminotransferase
Timepoint [4] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [5] 0 0
Change From Baseline in Plasma Alkaline Phosphatase
Timepoint [5] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [6] 0 0
Change From Baseline in Plasma Amylase
Timepoint [6] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [7] 0 0
Change From Baseline in Plasma Aspartate Aminotransferase
Timepoint [7] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [8] 0 0
Change From Baseline in Plasma Bicarbonate
Timepoint [8] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [9] 0 0
Change From Baseline in Plasma Bilirubin
Timepoint [9] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [10] 0 0
Change From Baseline in Plasma C Reactive Protein
Timepoint [10] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [11] 0 0
Change From Baseline in Plasma Calcium
Timepoint [11] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [12] 0 0
Change From Baseline in Plasma Chloride
Timepoint [12] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [13] 0 0
Change From Baseline in Plasma Cholesterol
Timepoint [13] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [14] 0 0
Change From Baseline in Plasma Creatine Kinase
Timepoint [14] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [15] 0 0
Change From Baseline in Plasma Creatinine
Timepoint [15] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [16] 0 0
Change From Baseline in Plasma Cystatin C
Timepoint [16] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [17] 0 0
Change From Baseline in Plasma Direct Bilirubin
Timepoint [17] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [18] 0 0
Change From Baseline in Plasma Glucose
Timepoint [18] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [19] 0 0
Change From Baseline in Plasma HDL Cholesterol
Timepoint [19] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [20] 0 0
Change From Baseline in Plasma Indirect Bilirubin
Timepoint [20] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [21] 0 0
Change From Baseline in Plasma LDL Cholesterol
Timepoint [21] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [22] 0 0
Change From Baseline in Lactate Dehydrogenase
Timepoint [22] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [23] 0 0
Change From Baseline in Plasma Pancreatic Lipase
Timepoint [23] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [24] 0 0
Change From Baseline in Plasma Magnesium
Timepoint [24] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [25] 0 0
Change From Baseline in Plasma Phosphate
Timepoint [25] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [26] 0 0
Change From Baseline in Plasma Potassium
Timepoint [26] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [27] 0 0
Change From Baseline in Plasma Protein
Timepoint [27] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [28] 0 0
Change From Baseline in Prothrombin Intl. Normalised Ratio
Timepoint [28] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [29] 0 0
Change From Baseline in Prothrombin Time
Timepoint [29] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [30] 0 0
Change From Baseline in Plasma Sodium
Timepoint [30] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [31] 0 0
Change From Baseline in Plasma Triglycerides
Timepoint [31] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [32] 0 0
Change From Baseline in Plasma Urate
Timepoint [32] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [33] 0 0
Change From Baseline in Plasma Urea Nitrogen
Timepoint [33] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [34] 0 0
Change From Baseline in Basophils
Timepoint [34] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [35] 0 0
Change From Baseline in Basophils/Leukocytes
Timepoint [35] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [36] 0 0
Change From Baseline in Eosinophils
Timepoint [36] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [37] 0 0
Change From Baseline in Eosinophils/Leukocytes
Timepoint [37] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [38] 0 0
Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration
Timepoint [38] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [39] 0 0
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin
Timepoint [39] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [40] 0 0
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Timepoint [40] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [41] 0 0
Change From Baseline in Erythrocytes
Timepoint [41] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [42] 0 0
Change From Baseline in Hematocrit
Timepoint [42] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [43] 0 0
Change From Baseline in Hemoglobin
Timepoint [43] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [44] 0 0
Change From Baseline in Leukocytes
Timepoint [44] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [45] 0 0
Change From Baseline in Lymphocytes
Timepoint [45] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [46] 0 0
Change From Baseline in Lymphocytes/Leukocytes
Timepoint [46] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [47] 0 0
Change From Baseline in Monocytes/Leukocytes
Timepoint [47] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [48] 0 0
Change From Baseline in Neutrophils
Timepoint [48] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [49] 0 0
Change From Baseline in Neutrophils/Leukocytes
Timepoint [49] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [50] 0 0
Change From Baseline in Platelets
Timepoint [50] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [51] 0 0
Change From Baseline in Reticulocytes/Erythrocytes
Timepoint [51] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [52] 0 0
Change From Baseline in Urine Albumin
Timepoint [52] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [53] 0 0
Change From Baseline in Urine Creatinine
Timepoint [53] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Primary outcome [54] 0 0
Change From Baseline in Urine Protein
Timepoint [54] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Secondary outcome [1] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24
Timepoint [1] 0 0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Secondary outcome [2] 0 0
Proportion of Subjects Achieving Complete or Partial Renal Remission at Week 12 and Week 24
Timepoint [2] 0 0
Endpoint at Week 12 for Double-Blind Treatment Period and Endpoint at Week 24 for Open-Label Extension

Eligibility
Key inclusion criteria
1. Male or female subjects aged 18-75
2. UPCR = 1 g protein/g creatinine (or at 113 mg.mmol) at screening
3. Diagnosis of FSGS based on renal biopsy or high risk genetic variant
4. Diagnosis of one of primary FSGS based on characteristic histopathology, medical history and clinical course or FSGS secondary to genetic variants associated with increased risk or severity.
5. Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2
6. Clinical stable blood pressure not to exceed 145/95 mmHg
7. RAAS blockers must be stable for at least 4 weeks prior to screening and projected to remain stable through week 12, unless adjustments are required for management of hypertension.
8. Immunosuppressive or immunomodulatory therapy must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12
9. Glucocorticoids must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12.
10. Both genders of childbearing potential must agree to use adequate contraception during and for at least 3 months after the last dose of study drug.
11. Subjects must be willing and able to give written Informed Consent and to comply with protocol requirements.
12. Subjects must be judged to be otherwise fit for the study by the Investigator. -
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant or nursing
2. History of organ transplantation
3. On an organ transplant waiting list or anticipated organ transplant within 6 months of screening
4. Anti-CD20 monoclonal antibodies within 20 months of screening are exclusionary. Subjects that used anti CD20 monoclonal antibodies prior to week 20 are allowed with confirmed recovery of CD20+ B cell population to within normal range
5. Plasmapheresis within 12 weeks of screening
6. BMI =40
7. Participation in any clinical study of an investigational product within 12 weeks or 5 half-lives of screening
8. Currently on dialysis or likely to require dialysis during the blinded treatment phase of the study.
9. History or presence of any form of cancer within 5 years of screening except excised basal cell or squamous cell carcinoma or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or completed resected without evidence or recurrence.
10. Positive HBV, HCV, or HIV viral screening test. Subjects who have received highly effective therapy for HCV demonstrated to have negative viral titers for at least 6 months following discontinuation of treatment, will be considered to have a negative HCV screening test
11. Renal disease associated with disorders other than FSGS that is active or has significant risk of progressing during the course of the study.
12. Disorders that are associated with FSGS lesions.
13. Evidence of tuberculosis.
14. Evidence of hepatic disease with the exception that isolated INR elevation in the absence of other significant liver enzyme abnormalities is explained by anticoagulant therapy, (e.g. warfarin)
15. Hematologic abnormalities as follows: Hb <8 g/dL, platelets <50,000, ANC <1000 cells/µL) at baseline.
16. QTcF greater than 450 msec.
17. History of alcohol or illicit drug abuse or of lithium, pamidronate and interferon. Recreational use of cannabis is not excluded where legal.
18. History of gastrointestinal conditions that may interfere with study medication compliance.
19. Known hypersensitivity to CCX140-B or inactive ingredients of the CCX140-B tablets (including microcrystalline cellulose, starch, crospovidone, magnesium stearate, or silicon dioxide).
20. History or presence of systemic disorder other than FSGS that requires, or is expected to require, systemic glucocorticoids or immune modulators during the study; topical or inhaled glucocorticoids and immune modulators are not excluded.
21. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation.
22. Subjects taking strong CYP3A4 inducers or strong CYP3A4 inhibitors within two weeks prior to screening.
23. Subjects taking lithium or interferon; subjects taking non-steroidal anti-inflammatory agents (NSAIDS) chronically (intermittent, i.e. occasional NSAIDS for pain or fever is discouraged, but is not excluded).

-

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/02/2020
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Austin Health - Heidelberg
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux
Country [13] 0 0
France
State/province [13] 0 0
Créteil
Country [14] 0 0
France
State/province [14] 0 0
Grenoble cedex 9
Country [15] 0 0
France
State/province [15] 0 0
Grenoble
Country [16] 0 0
France
State/province [16] 0 0
Marseille
Country [17] 0 0
France
State/province [17] 0 0
Metz
Country [18] 0 0
Italy
State/province [18] 0 0
Bergamo
Country [19] 0 0
Italy
State/province [19] 0 0
Genova
Country [20] 0 0
Italy
State/province [20] 0 0
Montichiari
Country [21] 0 0
Italy
State/province [21] 0 0
Pavia
Country [22] 0 0
Italy
State/province [22] 0 0
Rome
Country [23] 0 0
New Zealand
State/province [23] 0 0
Auckland
Country [24] 0 0
New Zealand
State/province [24] 0 0
New Plymouth
Country [25] 0 0
Poland
State/province [25] 0 0
Bialystok
Country [26] 0 0
Poland
State/province [26] 0 0
Kraków
Country [27] 0 0
Poland
State/province [27] 0 0
Szczecin
Country [28] 0 0
Poland
State/province [28] 0 0
Wroclaw
Country [29] 0 0
Poland
State/province [29] 0 0
Lódz
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Cambridge
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Cardiff
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Salford
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ChemoCentryx
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Staehr, MD
Address 0 0
ChemoCentryx
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03536754