Trials / Completed
CompletedNCT02437422
Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease
A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients With End-Stage Renal Disease (ESRD)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Prolong Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease (ESRD).
Detailed description
The purpose of the study is to investigate the safety of SANGUINATE on humoral sensitization in End Stage Renal Disease (ESRD) patients receiving dialysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SANGUINATE | Single two-hour infusion of SANGUINATE |
Timeline
- Start date
- 2015-06-05
- Primary completion
- 2015-11-18
- Completion
- 2015-11-18
- First posted
- 2015-05-07
- Last updated
- 2018-05-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02437422. Inclusion in this directory is not an endorsement.