Determination of Prednisolone Pharmacokinetic and Pharmacodynamic Parameters in Dogs with Lymphoma or Immune-Mediated Diseases

Trial ended March 2022.

Patient Disease:

Canine Lymphoma or Immune-Mediated Disease

Study Name:

Determination of Prednisolone Pharmacokinetic and Pharmacodynamic Parameters in Dogs with Lymphoma or Immune-Mediated Diseases

Purpose of the study:

To determine the plasma blood levels (pharmacokinetic parameters) as well as measures of immune system modulation (pharmacodynamics parameters) in dogs with lymphoma or immune mediated disease before and after oral administration of prednisolone using one of two commonly recommended doses

Primary Eligibility Criteria:

  • Dogs with a confirmed diagnosis of lymphoma or immune-mediated disease
  • Weight at least 10 kg (22 lb)
  • Good function of liver and kidneys, acceptable blood cell counts, and free of severe underlying disease
  • 7-day washout from treatment with corticosteroids or other immunosuppressive drugs
  • No dogs with immune-mediated disease of the gastrointestinal tract or liver
  • Pets must come to CSU for all visits related to the clinical trial

Study Protocol:

  • Within 14 days of starting the study treatment, dogs must have a complete blood count, chemistry profile, and urinalysis +/- urine protein creatinine ratio to determine study eligibility
  • On Day 0, dogs will have a physical exam, lymph node aspirate, baseline blood samples collection, receive his/her first dose of prednisolone, and then have serial blood samples collected for 8 hours after administration
  • Dogs will return the following day for additional blood sample collection and a lymph node aspirate
  • Owners will continue to administer the oral prednisolone at home once daily
  • Dogs will return on Day 7 for a recheck examination, blood work, urinalysis, and collection of additional blood samples
  • After this visit, clinical trial participation will be complete

Owner Responsibilities:

  • Administer oral medication to their dogs
  • Follow appointment schedule required by study protocol
  • Costs associated with tests to obtain diagnosis of lymphoma or immune-mediated disease and determine study eligibility, and any other tests/treatments recommended by the clinician

Financial Incentives:

  • The study will cover all costs related to the study, including collection of study blood samples, complete blood count 24 hours after prednisolone dosing, and blood work and urinalysis pre-treatment and on Day 7
  • The study will also cover the cost of overnight hospitalization if needed on Day 0 and the cost of the recheck exam fee on Day 7
  • A $150 credit will be applied to the patient’s VTH account at the time of study completion to be used for future treatment

If you have further questions about any of our clinical trials, please submit an online consult form. Your consult will then be directed to our trials team. Requests are typically returned within 5 business days.

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