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Clinical Trials/CTRI/2015/06/005916
CTRI/2015/06/005916
Not yet recruiting
Phase 3

â??A multicentre, prospective, study to evaluate the safety and efficacy of PEGEPO(Pegylated Erythropoietin) in healthy volunteers and patients with chronic renalfailure.â??

Cadila Healthcare Limited0 sites36 target enrollmentTBD
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ConditionsHealth Condition 1: N189- Chronic kidney disease, unspecifiedHealth Condition 2: null- predialysispatients with chronic renal failure(Part B)

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: N189- Chronic kidney disease, unspecifiedHealth Condition 2: null- predialysispatients with chronic renal failure(Part B)
Sponsor
Cadila Healthcare Limited
Enrollment
36
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female patients diagnosed with chronic renal failure (GFR 15\-60 mL/min/1\.73
  • •m2\), aged 18 to 65 years (including both).
  • •2\. Pre\-dialysis patients (Part B) and patients receiving regular haemodialysis two to three
  • •times per week for at least 8 weeks (Part C).
  • •3\. Patients having haemoglobin level 6\.5\-10 gm/dL at screening visit.
  • •4\. Patients with at least 20% of TSAT and \>\=200 ng/mL of ferritin at screening.
  • •5\. Subject has given informed consent for participation in this trial

Exclusion Criteria

  • •1\.Pregnancy and lactation.
  • •2\. Patients with uncontrolled hypertension (patients with over 100 mm Hg of diastolic
  • •blood pressure)
  • •3\. Acute Renal Failure
  • •4\. Evidence of Vitamin B12 or folic acid deficiency anaemia,
  • •5\. Subjects having any other known cause of anaemia.
  • •6\. Patients with congestive heart failure (CHF) of grade III or higher (as per New York
  • •Heart Association Class III)
  • •7\. Patients with malignancy (including hematologic malignancy), systemic blood disorder
  • •(myelodysplastic syndrome, pure red cell aplasia, haemolytic anaemia etc.)

Outcomes

Primary Outcomes

Not specified

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