Phase 2 Dose Finding sPIF in Patients With High Panel Reactive Antibodies

Christopher O'Brien, MD

Status and phase: Withdrawn; Phase 2

Conditions: Panel Reactive Antibodies

Treatments: Drug: synthetic PreImplantation Factor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03593421

sPIF-US-PRA-001 (Other Identifier)

20171060

Details and patient eligibility

About

This is an open labeled dose finding adaptive design study. Patients with elevated cPRA values, 30-60% will be recruited and administered sPIF injected subcutaneously for 14 doses; one dose on Monday, Wednesday, Friday, or Tuesday, Thursday, Saturday, per individual patient dialysis schedule.

Full description

The purpose of this study is to determine the sPIF dose that reduces serum cPRA to <30%, when administered 14 doses. Safety, tolerability, and efficacy will be evaluated at day 42 and and day 84. The suitability of a patient to receive a kidney transplant will also be monitored up to 6 months after Day 84. Safety and tolerability will be assessed at each of the increased doses and throughout the treatment duration. Exploratory analysis of blood indices will be carried out and changes based on history, physical and laboratory exams will be assessed according to the 12 systems.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Outpatient male and females 18-75 years old
• Able and willing to give written informed consent and comply with the requirements of the study protocol
• Calculated panel reactive antibody (cPRA) >30% and <60% with a threshold using mean fluorescent intensity (MFI) of 3,000 or standard fluorescence intensity (SFI) of 60,000 over six months.
• Women who are of childbearing potential must have a negative serum pregnancy test prior to being enrolled in the study and agree to use effective method of contraception throughout the 84-day study.
• Patients on kidney dialysis 3.3 Exclusion Criteria
• Patients not capable of following through the treatment for various reasons as determined by treating physicians
• Pregnant females
• Requiring blood transfusions
• Have an active infection
• Infection with hepatitis C virus (HCV) or hepatitis B virus(HBV) or human immunodeficiency virus (HIV), lack of documentation of treatment of a positive PPD, baseline leukopenia, white blood cell count (WBC) <4.0, thrombocytopenia (platelet count <100,000/mm) or difficult to treat anemia, a hematocrit chronically <25% on intravenous iron and EPO (erythropoietin) therapy
• Active cancer within 5 years
• Significant cardiac or pulmonary disease (including obstructive pulmonary disease)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 5 patient groups

synthetic preImplantation factor 1 mg/kg

Experimental group

Description:

Patients will be dosed SQ with 14 doses of sPIF

Treatment:

Drug: synthetic PreImplantation Factor

synthetic preImplantation factor 2 mg/kg

Experimental group

Description:

Patients will be dosed SQ with 14 doses of sPIF

Treatment:

Drug: synthetic PreImplantation Factor

synthetic preImplantation factor 3 mg/kg

Experimental group

Description:

Patients will be dosed SQ 14 doses

Treatment:

Drug: synthetic PreImplantation Factor

synthetic preImplantation factor 4 mg/kg

Experimental group

Description:

Patients will be dosed SQ with 14 doses of sPIF

Treatment:

Drug: synthetic PreImplantation Factor

synthetic preImplantation factor 5 mg/kg

Experimental group

Description:

Patients will be dosed SQ with 14 doses of sPIF

Treatment:

Drug: synthetic PreImplantation Factor