Renal AnemiaPhase 4NCT04454879
Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients
A Phase 4 study testing Roxadustat in people with Renal Anemia, run by Peking University First Hospital at 1 site in China.
Trial summary
A multi-center, randomized, controlled study to evaluate the effect of different doses of roxadustate on hemoglobin target-met in peritoneal dialysis patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Anemia
- What is being tested?
- Roxadustat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 3 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients diagnosed with Chronic kidney disease stage 5
- Maintenance on PD for more than three months.
- Weight between 45Kg and 110Kg
- Renal anemia, and hemoglobin between 90g/L and 120g/L
- Stop taking erythropoietin for enough time （erythropoietin treatment discontinuation for ≥3 days if using erythropoietin of 3000U single strength, or ≥7 days if using erythropoietin of 10000U single strength） or free of erythropoietin use
- Signed the informed consent.
- Willing to follow the study procedure
Who cannot join
- Hematologic malignancy or aplastic anemia.
- Blood loss or hemolysis.
- Taking roxadustat, or Allergy or intolerance to roxadustat
- Severe liver injury or active hepatitis.
- Pregnancy or breastfeeding
- Cancer, receiving radiotherapy and chemotherapy within 6 months.
- Refractory hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Doses of Roxadustat Treatment on Hemoglobin Target-met in Peritoneal Dialysis Patients
A multi-center, randomized, controlled study to evaluate the effect of different doses of roxadustate on hemoglobin target-met in peritoneal dialysis patients
Read the detailed description
Roxadustat is an orally hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to promote erythropoiesis on patients with chronic kidney disease. Two phase 3 clinical trials have verified the efficacy and safety of roxadustate as therapy for anemia in patients with CKD and undergoing dialysis. A high increasing rate of Hb or Hb overshooting triggered by roxadustat need dosing reduction or even drug withdrawal, possibly leading to a large Hb variation and adverse subsequences. Therefore, we were of interest to investigate whether a lower starting dose of roxadustat could achieve comparable Hb target at week 12 while lowering the risk for Hb over 130g/L through a prospective peritoneal dialysis (PD) cohort. Peritoneal dialysis patients diagnosed with renal anemia will be divided into standard roxadustat dosage group and lower roxadustat dosage group. After 12 weeks, we will compare the target-met, overshooting and variation ratio of hemoglobin between these two groups.
- Conditions
- Renal Anemia
- Being tested
- Roxadustat
- Keywords
- Roxadustat, renal anemia, Peritoneal Dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
Patients in the standard dosage group will receive starting dosage of roxadustat 100 mg, three times per week for weight 45-60kg and 120 mg, three times per week for weight greater than 60kg. Patients in the lower dosage group will receive the starting dosage of roxadustat 50 mg, three times per week for weight lower than 50kg, 70 mg, three times per week for weight 50-70kg, 90 mg, three times per week for weight 70-90kg and 110 mg, three times per week for weight 90-110kg, respectively.
| Study group | Role | What they receive |
|---|---|---|
| standard roxadustat dosage group | Experimental | Peritoneal dialysis patients diagnosed with renal anemia will receive standard dosage of roxadustat according to weight. Receives: Drug: Roxadustat |
| lower roxadustat dosage group | Experimental | Peritoneal dialysis patients diagnosed with renal anemia will receive lower dosage of roxadustat according to weight. Receives: Drug: Roxadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of hemoglobin achieving the target (115g/L)
The ratio of hemoglobin achieving the target (115g/L) on week 8 and week 12.
Measured: 12 weeks
Secondary outcomes (2)
The variation ratio of hemoglobin
The standard deviation of hemoglobin during the follow-up divide by average of hemoglobin
Measured: 12 weeks
The ratio of hemoglobin over-shooting
Hemoglobin higher than 130g/L during the follow-up.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jul 2020
- Primary completion3 Apr 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal AnemiaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Haidian Hospital, Beijing Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
- Investigators
- Jie Dong, MD, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454879
- Sponsor's protocol ID
- Roxadustat，different dose,
- Status last verified
- Nov 2021
- First submitted
- 29 Jun 2020
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Z, Ma T, Xu X, Fu G, Zhao J, Xu Y, Yang B, Song D, Zhu S, Lv J, Dong J. Randomized Study on the Efficacy of Standard Versus Low Roxadustat Dose for Anemia in Patients on Peritoneal Dialysis. Kidney Int Rep. 2021 Dec 27;7(3):455-464. doi: 10.1016/j.ekir.2021.12.025. eCollection 2022 Mar.
PubMed 35257058
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Doses of Roxadustat Treatment on Hemoglobin Target-met in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT04454879
- Acronym / sponsor ID
- Roxadustat，different dose,
- Conditions
- Renal Anemia
- Keywords
- Roxadustat, renal anemia, Peritoneal Dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Beijing Haidian Hospital, Beijing Hospital of Traditional Chinese Medicine
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 3 Apr 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, randomized, controlled study to evaluate the effect of different doses of roxadustate on hemoglobin target-met in peritoneal dialysis patients
Detailed description
Roxadustat is an orally hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to promote erythropoiesis on patients with chronic kidney disease. Two phase 3 clinical trials have verified the efficacy and safety of roxadustate as therapy for anemia in patients with CKD and undergoing dialysis. A high increasing rate of Hb or Hb overshooting triggered by roxadustat need dosing reduction or even drug withdrawal, possibly leading to a large Hb variation and adverse subsequences. Therefore, we were of interest to investigate whether a lower starting dose of roxadustat could achieve comparable Hb target at week 12 while lowering the risk for Hb over 130g/L through a prospective peritoneal dialysis (PD) cohort. Peritoneal dialysis patients diagnosed with renal anemia will be divided into standard roxadustat dosage group and lower roxadustat dosage group. After 12 weeks, we will compare the target-met, overshooting and variation ratio of hemoglobin between these two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard roxadustat dosage group | Experimental | Drug: RoxadustatPeritoneal dialysis patients diagnosed with renal anemia will receive standard dosage of roxadustat according to weight. |
| lower roxadustat dosage group | Experimental | Drug: RoxadustatPeritoneal dialysis patients diagnosed with renal anemia will receive lower dosage of roxadustat according to weight. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients diagnosed with Chronic kidney disease stage 5
- Maintenance on PD for more than three months.
- Weight between 45Kg and 110Kg
- Renal anemia, and hemoglobin between 90g/L and 120g/L
- Stop taking erythropoietin for enough time （erythropoietin treatment discontinuation for ≥3 days if using erythropoietin of 3000U single strength, or ≥7 days if using erythropoietin of 10000U single strength） or free of erythropoietin use
Key exclusion criteria (7 listed)
- Hematologic malignancy or aplastic anemia.
- Blood loss or hemolysis.
- Taking roxadustat, or Allergy or intolerance to roxadustat
- Severe liver injury or active hepatitis.
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoxadustatPatients in the standard dosage group will receive starting dosage of roxadustat 100 mg, three times per week for weight 45-60kg and 120 mg, three times per week for weight greater than 60kg. Patients in the lower dosage group will receive the starting dosage of roxadustat 50 mg, three times per week for weight lower than 50kg, 70 mg, three times per week for weight 50-70kg, 90 mg, three times per week for weight 70-90kg and 110 mg, three times per week for weight 90-110kg, respectively. | Drug | lower roxadustat dosage group, standard roxadustat dosage group |
Primary outcome
The ratio of hemoglobin achieving the target (115g/L)
Time frame: 12 weeks
The ratio of hemoglobin achieving the target (115g/L) on week 8 and week 12.
2 secondary outcomes
The variation ratio of hemoglobin
Time frame: 12 weeks
The ratio of hemoglobin over-shooting
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Derived from this study: PubMed 35257058Yang Z, Ma T, Xu X, Fu G, Zhao J, Xu Y, Yang B, Song D, Zhu S, Lv J, Dong J. Randomized Study on the Efficacy of Standard Versus Low Roxadustat Dose for Anemia in Patients on Peritoneal Dialysis. Kidney Int Rep. 2021 Dec 27;7(3):455-464. doi: 10.1016/j.ekir.2021.12.025. eCollection 2022 Mar.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Dong, MD study director
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roxadustat in people with Renal Anemia, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of hemoglobin achieving the target (115g/L) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04454879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.