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Completed

NCT Number: NCT02384317

Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade

The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with IgAN on background supportive therapy with a maximally tolerated dose of RAAS blockade. The primary efficacy objective is to evaluate the efficacy of CCX168 based on an improvement in proteinuria.

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Key information

Conditions

Immunoglobulin A Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stockholm, Sweden

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About this study

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Diagnosis of Immunoglobulin A nephropathy
  • estimated glomerular filtration rate >60 mL/min/1.73 m2
  • Proteinuria (first morning urinary protein:creatinine ratio >1g/g creatinine)

Key Exclusion Criteria:

  • Severe renal disease
  • Pregnant or nursing
  • Proteinuria >8g/g creatinine or >8g/day
  • Systemic manifestations of Henoch-Schonlein purpura within 2 years prior
  • Patients with Immunoglobulin A nephropathy deemed secondary to underlying disease
  • Biopsy reported severe crescentic Immunoglobulin A nephropathy
  • History of treatment with glucocorticoids, cyclophosphamide, azathioprine, mycophenolate mofetil, or any biologic immunomodulatory agent with 24 weeks prior
  • History of clinically significant cardiac conditions
  • History of cancer within 5 years prior
  • Any infection requiring antibiotic treatment that has not cleared prior to study start

Treatment and study plan

CCX168

Drug

CCX168 30 mg, twice daily (b.i.d.) orally for 84 days (12 weeks). The CCX168 dose was taken in the morning, optimally within one hour after breakfast, and in the evening, optimally within one hour after dinner.

Primary outcomes

  1. Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 Treatment Period

    Time frame: Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period)

    The mean change in the slope of the urinary protein:creatinine ratio (UPCR, in mg/g/week) between the 8-week run-in period and the 12-week treatment period

  2. Number of Participants With AE's

    Time frame: Day 0 - Day 169 (throughout the trial)

    Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)

  3. Severity of Adverse Events (AE's)

    Time frame: Day 0 - Day 169 (throughout the trial)

    Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)

Secondary outcomes

  1. Proportion of Subjects Achieving Renal Response From Baseline to Day 85

    Time frame: Baseline and Day 85

    Renal Response defined as an improvement in proteinuria based on a decrease from baseline to Day 85 in proteinuria to a level <300 mg/g creatinine and maintaining eGFR within 15% of baseline.

  2. Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85

    Time frame: Baseline and Day 85

    A partial renal response, defined as an improvement in proteinuria based on a decrease from baseline to Day 85 in proteinuria to a level <1 g/g creatinine and maintaining eGFR within 15% of baseline.

  3. Change From Baseline to Day 85 in Vital Signs

    Time frame: Baseline to day 85

  4. Change in Systolic Blood Pressure From Baseline to Day 85

    Time frame: Baseline to day 85

  5. Change in Diastolic Blood Pressure From Baseline to Day 85

    Time frame: Baseline to day 85

  6. Change in Temperature From Baseline to Day 85

    Time frame: Baseline to day 85

  7. Change in Weight From Baseline to Day 85

    Time frame: Baseline to day 85

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Immunoglobulin A Nephropathy on Stable RAAS Blockade

Important dates

Study start
2015
Primary completion
2015
Study completion
2018
First posted
Mar 10, 2015
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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