The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group

Labbafinejhad Hospital

Status and phase: Unknown; Phase 1

Conditions: Transplantation, Kidney

Treatments: Drug: Placebo; Drug: Erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT00617474

200786

L1386

Details and patient eligibility

About

The study hypothesis is that erythropoietin usage after kidney transplantation, in early phase, can improve the outcome for patients and their graft increasing patient and graft survival.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Hb: >8 and <10 gr/dl
• Age: >18 and <55 years
• Cholesterol: <300 mg/dl
• Triglyceride: <400 mg/dl
• First Transplantation
• Protocol of Immunosuppression: CSA + MMF + Prednisolone
• Systolic BP: <14
• Diastolic BP: <9

Exclusion criteria

• History of specified cardiac disease
• Second Transplantation or more
• Hb: <7gr/dl
• The patient needs to infusion of blood
• Evidence of local or systemic infection, at the time of EPO injection
• Presence of ATN / DGF after transplantation
• Presence of emergent hypertension
• High risk patients ( Like; PRA>50%)
• Past history of hypersensitivity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Group of patient with anemia, that treated by erythropoietin

Treatment:

Drug: Erythropoietin

2

Placebo Comparator group

Description:

Patients group with anemia that treated by placebo

Treatment:

Drug: Placebo