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A Study of Patients With Chronic Kidney Disease to Assess the Safety of a Single Dose of COR-001 (COR-001-SC1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03126318
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Corvidia Therapeutics
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Drug: COR-001 Drug: Placebo Phase 1

Detailed Description:

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 (CKD) and persistent inflammation (defined as a persistently elevated serum CRP (C-Reactive Protein) level). The primary objective is to evaluate the safety of a single dose of the study drug delivered subcutaneously. Four CKD patients will be randomized to the study drug or placebo within each dosing cohort in a ratio of 3:1. The dosing cohorts are 5 mg, 15 mg, 50 mg, and 100 mg. Each patient will be given 1 dose of the study drug and then be followed for 12 weeks for primary safety, pharmacokinetic and pharmacodynamic assessments. Next, patients will continue to be followed for an additional 20 weeks (32 weeks observation in total) for safety and anti-drug antibody assessments.

Prior to dose escalation (i.e., higher total dose than studied in the preceding cohorts), there will be a formal safety review and the data will have been determined to be acceptable by a Data Safety Monitoring Board (DSMB) which will include at least one nephrologist. The safety review required for dose escalation will include at least 21 days of treatment data from the preceding cohort(s). The DSMB will also meet to review data concerning an SAE (Serious Adverse Event) that is suspected to be study drug related

The investigative team (other than an un-blinded research pharmacist or equivalent) will be blinded to the treatment assignment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, placebo-controlled - 4 cohorts of 4 patients each with a dosing regimen of 3:1 (active:placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Cohort Dose-Escalation Study in Patients With Chronic Kidney Disease to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of COR-001 (COR-001-SC1)
Actual Study Start Date : May 19, 2017
Actual Primary Completion Date : March 14, 2019
Actual Study Completion Date : December 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: COR-001
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
Anti-inflammatory therapy

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




Primary Outcome Measures :
  1. The safety of a 5 mg dose of COR-001 as measured by the incidence of adverse events [ Time Frame: 1 month after the 4th patient has received study drug ]
    To evaluate the safety of a 5 mg dose of COR-001 delivered subcutaneously

  2. The safety of a 15 mg dose of COR-001 as measured by the incidence of adverse events [ Time Frame: 1 month after the 4th patient has received study drug ]
    To evaluate the safety of a 15 mg dose of COR-001 delivered subcutaneously

  3. The safety of a 50 mg dose of COR-001 as measured by the incidence of adverse events [ Time Frame: 1 month after the 4th patient has received study drug ]
    To evaluate the safety of a 50 mg dose of COR-001 delivered subcutaneously

  4. The safety of a 100 mg dose of COR-001 as measured by the incidence of adverse events [ Time Frame: 1 month after the 4th patient has received study drug ]
    To evaluate the safety of a 100 mg dose of COR-001 delivered subcutaneously


Secondary Outcome Measures :
  1. Pharmacokinetic analysis: maximum serum drug concentrations (Cmax) [ Time Frame: Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose. ]
    To evaluate single-dose pharmacokinetics of COR-001 delivered subcutaneously

  2. Pharmacokinetic analysis: area under the serum drug concentration-time curve (AUC) [ Time Frame: Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose. ]
    To evaluate the single-dose pharmacokinetics of COR-001 delivered subcutaneously

  3. Pharmacokinetic analysis: terminal elimination half-life (t1/2) [ Time Frame: Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose. ]
    To evaluate the single-dose pharmacokinetics of COR-001 delivered subcutaneously

  4. The effectiveness of COR-001 as measured by levels of an inflammatory marker [ Time Frame: Screening and at weeks 1 - 5, 8, 12, 20, and 32. ]
    To evaluate the effectiveness of COR-001 as measured by CRP levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with advanced CKD requiring chronic dialysis
  2. Hospitalization over the period of 6 weeks prior to randomization
  3. Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs anytime during the study Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary.
  4. History of or expected to undergo living related kidney transplant during the study period
  5. Currently receiving or planning to receive live or inactivated vaccines
  6. Clinical evidence or suspicion of active or smoldering infection (e.g., diabetic foot ulcer) or use of antibiotics during the Screening period
  7. History of a positive PPD or prior diagnosis of tuberculosis
  8. Evidence of HIV infection or carrier state by serology at Screening
  9. Hepatitis B or C by serology (i.e. Hepatitis B Surface Antigen or Hepatitis C antibody positive) at Screening
  10. AST or ALT > 2.5x ULN at Screening
  11. History of liver cirrhosis or home oxygen use
  12. History of gastrointestinal ulceration or active diverticulitis in the 1 year prior to Screening
  13. Absolute neutrophil count < 2 x 109/L at Screening
  14. Platelet count < 100 x 109/L at Screening
  15. Participated in an investigational drug study within 30 days of Screening or Screening is within 5 half-lives of the investigational compound.
  16. Known allergy to the study drug or any of its ingredients
  17. Breastfeeding or a positive pregnancy test at Screening or Day -1.
  18. Any condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would in the opinion of the Investigator increase the risk of the subject's participation in the study.

    This would include but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy, anemia attributable to a primary hematologic disease (e.g., sickle cell anemia), or any unexplained blackouts.

  19. Actively treated malignancy (other than non-melanoma skin cancers) during the 1 year prior to Screening. Patients receiving hormonal treatment only during this period only may be enrolled with the approval of the medical monitor.
  20. Myocardial infarction during the 3 months prior to Screening or during Screening
  21. Severe arthritis, lupus, inflammatory bowel disease, asthma or other disease(s) or medical condition(s) that, in the opinion of the investigator, could interfere with hs-CRP or immune function
  22. Use of CYP substrates with a narrow therapeutic index (please see detailed table below).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126318


Locations
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United States, Colorado
University of Coloardo Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Corvidia Therapeutics
Investigators
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Principal Investigator: Michel Chonchol, MD University of Colorado - Anschutz Medical Campus
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03126318    
Other Study ID Numbers: 16-2272
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency