Completed PHASE3 INTERVENTIONAL 3-arm NCT00598442

Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis (PEARL 2)

AFX01-13: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment

Sponsor: Affymax

Conditions Anemia Chronic Kidney Disease Chronic Renal Failure

Interventions Darbepoetin alfa peginesatide

Updated 7 times since 2017 Last updated: Feb 6, 2013 Started: Nov 30, 2007 Primary completion: Jul 31, 2009 Completion: Dec 31, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00598442, this PHASE3 trial focuses on Anemia and Chronic Kidney Disease and remains completed. Sponsored by Affymax, it has been updated 7 times since 2007, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Nov 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Affymax
Takeda

Data source: Affymax

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ames, United States , Arlington, United States , Asheville, United States , Balatonfüred, Hungary , Baton Rouge, United States , Bend, United States , Bialystok, Poland , Burlington, United States , Caldwell, United States , Canton, United States and 51 more locations