A Study of Patients With Chronic Kidney Disease to Assess the Safety of a Single Dose of COR-001

NCT03126318 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 16-2272
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo administered subcutaneously to patients with moderate-to-severe chronic kidney disease and persistent inflammation.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (4)

• The safety of a 5 mg dose of COR-001 as measured by the incidence of adverse events

  To evaluate the safety of a 5 mg dose of COR-001 delivered subcutaneously

  1 month after the 4th patient has received study drug

• The safety of a 15 mg dose of COR-001 as measured by the incidence of adverse events

  To evaluate the safety of a 15 mg dose of COR-001 delivered subcutaneously

  1 month after the 4th patient has received study drug

• The safety of a 50 mg dose of COR-001 as measured by the incidence of adverse events

  To evaluate the safety of a 50 mg dose of COR-001 delivered subcutaneously

  1 month after the 4th patient has received study drug

• The safety of a 100 mg dose of COR-001 as measured by the incidence of adverse events

  To evaluate the safety of a 100 mg dose of COR-001 delivered subcutaneously

  1 month after the 4th patient has received study drug

Secondary Outcomes (4)

• Pharmacokinetic analysis: maximum serum drug concentrations (Cmax)

  Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.

• Pharmacokinetic analysis: area under the serum drug concentration-time curve (AUC)

  Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.

• Pharmacokinetic analysis: terminal elimination half-life (t1/2)

  Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.

• The effectiveness of COR-001 as measured by levels of an inflammatory marker

  Screening and at weeks 1 - 5, 8, 12, 20, and 32.

Study Arms (2)

COR-001

ACTIVE COMPARATOR

COR-001 5, 15, 50, or 100 mg dose (depending on dose cohort assigned to patient) given by subcutaneous injection one time only

Drug: COR-001

Placebo

PLACEBO COMPARATOR

Placebo at pH 6.0will be given in a volume to match the volume of COR-001 being given for the dose cohort by subcutaneous injection one time only

Drug: Placebo

Interventions

COR-001 DRUG

Anti-inflammatory therapy

COR-001

Placebo DRUG

Sterile water with a final buffer of 25 mM Histidine, 8.5% (w/v) trehalose and 0.05% PS80

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CKD stage III or IV
• Serum CRP \> 2 mg/L measured twice during the Screening period at least one week apart
• Urine protein excretion \< 3.5 g/24h estimated by a spot urine protein/creatinine ratio
• The patient agrees to comply with the contraception and reproduction restrictions of the study - use 2 forms of acceptable contraception

You may not qualify if:

• Patients with advanced CKD requiring chronic dialysis
• Hospitalization over the period of 6 weeks prior to randomization
• History of or expected to undergo living related kidney transplant during the study period
• Currently receiving or planning to receive live or inactivated vaccines
• Clinical evidence or suspicion of active or smoldering infection (e.g., diabetic foot ulcer) or use of antibiotics during the Screening period
• History of a positive PPD or prior diagnosis of tuberculosis
• Evidence of HIV infection or carrier state by serology at Screening
• Hepatitis B or C by serology (i.e. Hepatitis B Surface Antigen or Hepatitis C antibody positive) at Screening
• AST or ALT \> 2.5x ULN at Screening
• History of liver cirrhosis or home oxygen use
• History of gastrointestinal ulceration or active diverticulitis in the 1 year prior to Screening
• Absolute neutrophil count \< 2 x 109/L at Screening
• Platelet count \< 100 x 109/L at Screening
• Participated in an investigational drug study within 30 days of Screening or Screening is within 5 half-lives of the investigational compound.
• Known allergy to the study drug or any of its ingredients

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Corvidia Therapeutics: collaborator

Study Sites (1)

University of Coloardo Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Nowak KL, Kakkar R, Devalaraja M, Lo L, Park W, Gobburu J, Kling D, Davidson M, Chonchol M. A Phase 1 Randomized Dose-Escalation Study of a Human Monoclonal Antibody to IL-6 in CKD. Kidney360. 2020 Dec 4;2(2):224-235. doi: 10.34067/KID.0005862020. eCollection 2021 Feb 25.

  PMID: 35373026 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel Chonchol, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled - 4 cohorts of 4 patients each with a dosing regimen of 3:1 (active:placebo)

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 24, 2017
• Study Start: May 19, 2017
• Primary Completion: March 14, 2019
• Study Completion: December 19, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)