NCT04502537

Brief Summary

A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the treatment of renal anemia, but there is a lack of evidence from cohort studies. A prospective cohort study is planed to conduct to evaluate the efficacy and safety of Roxadustat for renal anemia in the real world.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 22, 2021

Status Verified

October 1, 2020

Enrollment Period

2.4 years

First QC Date

August 3, 2020

Last Update Submit

January 19, 2021

Conditions

Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

  • Mean value of Hb levels over time

    Hb will be measured throughout the period.

    Up to Week 52

  • Achievement rate for target Hb level

    Percent of participants who achieved target Hb level (≥10.0 ).

    Up to Week 52

Secondary Outcomes (8)

  • Mean Hb levels at 4 weeks after using roxadustat

    At Week 4

  • Mean Hb levels at 8 weeks after using roxadustat

    At Week 8

  • the dose of Roxadustat used

    Up to Week 52

  • Change from baseline in Hemoglobin (Hb) levels

    Up to Week 52

  • the proportion of patients with different Hb levels

    Up to Week 52

  • +3 more secondary outcomes

Study Arms (2)

Roxadustat

treatment with roxadustat

Drug: Roxadustat

erythropoietin

treatment with erythropoietin

Drug: erythropoietin

Interventions

RoxadustatDRUG

Oral

Also known as: Roxadustat capsules
Roxadustat
erythropoietinDRUG

injection

Also known as: Recombinant Human Erythropoietin Injection(CHO cell)
erythropoietin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Renal anemia patients who are naïve to roxadustat or ESA

You may qualify if:

  • the patient did not receive ESA treatment.The average Hb level of the last two (at least 7 days before the start of the study treatment and during the screening period) was \<10 g/dL.
  • Or patients who have received ESA:
  • Patients with renal anemia who received ESA for at least 4 weeks within the approved dose range in China before the screening evaluation.
  • The average Hb level of the last two (at least 7 days before the start of the study treatment and during the screening period) \>=7 g/dL and \<=12.0 g/dL;
  • The expected survival time is more than 1 year;

You may not qualify if:

  • a history of severe, chronic, end-stage or uncontrolled autoimmune liver disease, Child Pugh score was grade C, or with active hepatitis;
  • preparing for pregnancy or pregnancy or lactation;
  • having anemia caused by any other disease other than CKD, such as thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, tumor-related anemia, chemotherapy-related anemia, and myelodysplastic syndrome;
  • malignant tumor, such as prostate cancer, breast cancer, renal cell cancer or any other malignant tumor history or diagnosed
  • Any red blood cell infusion during the screening period;
  • The patient is known to be allergic to the active substance (Roxadustat) or any excipient of the product;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, China

RECRUITING

MeSH Terms

Interventions

roxadustatErythropoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Yuan Cheng, Dr.

    Shenzhen Second People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Cheng, Dr.

CONTACT

86075583366388chengy_nephrology@163.com

Qijun Wan, Dr.

CONTACT

86075583366388yiyuan2224@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 6, 2020

Study Start

February 1, 2021

Primary Completion

June 30, 2023

Study Completion

September 30, 2023

Last Updated

January 22, 2021

Record last verified: 2020-10

Locations

CN(1)