Anemia of Chronic Kidney DiseasePhase 4NCT04655027
A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
A Phase 4 study testing Roxadustat and rHuEPO in people with Anemia of Chronic Kidney Disease, run by AstraZeneca at 8 sites in China.
Trial summary
This is a Phase IV, randomized, active-controlled, open-label, parallel design, multicenter prospective study to evaluate the effect of roxadustat versus rHuEPO treatment on the gastrointestinal (GI) iron absorption in patients with anemia of Stage 4 and Stage 5 CKD. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- Roxadustat and rHuEPO
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 8 sitesChina
- Study dates
- 22 Feb 2021to 12 Oct 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent • Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses.
- Type of patient and disease characteristics
- At Visit 1 prior to screening
- Dialysis patients:
- Patients receiving hemodialysis (HD) or peritoneal dialysis (PD) for treatment of end-stage renal disease (ESRD) for at least 12 weeks. Patients treated with HD must have access consisting of an arteriovenous (AV) fistula, AV graft, or tunneled (permanent) catheter. Patients on PD must have a functioning PD catheter in place.
- Hemodialysis patients should be on 3x/week dialysis with evidence of achievement of adequate dialysis as defined by standardized Kt/V ≥2.1 in HD, and total (renal + PD) weekly Kt/V ≥1.7 in PD documented twice during the 16 weeks preceding screening for the study.
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- Patients should be on a stable rHuEPO dose as defined by change in rHuEPO dose, not exceeding 20% within 4 weeks prior to screening.
- Non-dialysis patients:
- Patients with estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m^2, corresponding to Stage 4 or Stage 5 CKD according to the Kidney Disease Outcomes Quality Initiative (KDOQI), and not receiving dialysis.
- Patients should either be on a stable dose of rHuEPO for 4 weeks before screening or be rHuEPO-naïve.
- Dialysis and non-dialysis patients:
- Patients agree not to take any new traditional Chinese medicine (TCM) and not to change, dose, schedule or brand of any TCM from beginning of the Screening Period through the end of the Follow-up Period.
- At Visit 1 (screening)
- Ferritin ≥50 ng/mL and transferrin saturation (TSAT) ≥15% in non-dialysis patients
- Ferritin ≥100 ng/mL and TSAT ≥20% in dialysis patients.
- Dry body weight should be 45 to 100 kg.
- During the Screening Period:
- Dialysis patients must have a mean Hb level of ≥ 9 to ≤ 12 g/dL based on the mean of the 2 most recent central laboratory Hb values within 0.50 g/dL on 2 assays taken at least 7 days apart during the Screening Period.
- Non-dialysis patients must have a mean Hb level of ≥ 9 to ≤ 12 g/dL for rHuEPO-user patients and ≥ 7 and ≤ 10 g/dL for rHuEPO-naïve patients, based on the mean of the 2 most recent central laboratory Hb values within 0.50 g/dL on 2 assays taken at least 7 days apart during the Screening Period.
- At Visit 1 Screening:
- Serum folate level ≥ lower limit of normal (LLN).
- Serum vitamin B12 level ≥ LLN.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 x ULN and total bilirubin (TBL) ≤ 1.5 x ULN.
- Negative test results on the swab test to rule out active COVID-19 infection. If according to site procedures the test for COVID-19 infection cannot be performed at the first Screening Visit, the test should be performed as soon as possible thereafter but must be performed before the patient returns for the next study visit. Any patient who has had confirmed COVID-19 infection in the past, has fully recovered from symptoms at least 14 days prior to Screening, and has a negative swab test result for COVID-19 infection at Screening, may be included in the study.
- Reproduction:
- Serum pregnancy test should be negative for female of childbearing potential at the start of the Screening Period.
- Female patients of childbearing potential and male patients (non-surgically sterile) with a female partner of childbearing potential must, if not practicing complete sexual abstinence, agree to practice a dual method of contraception.
- Contraceptive methods must be practiced upon being randomized to the study and through 7 days after the last dose of study treatment. Male patients must not donate or bank sperm during this same time period.
Who cannot join
- Medical conditions
- New York Heart Association Class III or IV congestive heart failure (CHF) at screening.
- Acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
- History of severe, chronic, end-stage, or uncontrolled autoimmune liver disease with ALT 3 x ULN, or AST > 3 × ULN, or total bilirubin > 1.5 × ULN.
- Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red-cell aplasia or other known causes for anemia other than CKD.
- Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy.
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- Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg (confirmed by repeated measurement), within 2 weeks prior to randomization. Patients may be rescreened once BP is controlled.
- History of prostate cancer, breast cancer, renal cell carcinoma or any other malignancy, except the following: cancers determined to be cured or in remission for ≥5 years; curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
- Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythromatosus (SLE), ankylosing spondylitis, psoriatic arthritis or active inflammatory bowel disease that is determined to be the principal cause of anemia.
- Known hemosiderosis, hemochromatosis or hypercoagulable condition.
- Any prior organ transplant or a scheduled organ transplantation date.
- Any current condition leading to active significant blood loss.
- Known allergy to the study treatment or any of its ingredients.
- Any medical condition, including active, clinically significant infection, that in the opinion of the Investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment or may interfere with study participation.
- Intolerance of oral iron in the past as defined by stomach upset, nausea, vomiting, or diarrhea.
- Active GI bleed.
- Hospitalizations within the 12 weeks preceding study randomization for GI bleeding or Congestive heart failure.
- Life expectancy <6 months.
- Patients who are likely to be initiated on dialysis within the next 3 months per Investigator's assessment at the time of screening.
- Previous bowel resection.
- Coeliac disease.
- Gastroenteritis in the 4 weeks prior to randomization.
- Cognitive disabilities, physical or psychiatric disease that in the opinion of the Investigator/clinician influence the patient's adherence and successful completion of the study.
- Prior/concomitant therapy:
- Any treatment with roxadustat or a Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors (HIF-PHI).
- Any red blood cells transfusion within 6 weeks prior to the first Screening Visit, or during the Screening Period.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within the 12 weeks prior to Screening Visit.
- Exposure to IV iron or use of TRIFERIC® in dialysate during the Screening Period (ie, 2 weeks before randomization [Day 1]).
- Exposure to iron-chelating agent (eg, deferoxamine/desferrioxamine, deferiprone or deferaxirox therapy) within the 6 weeks prior to the first Screening Visit.
- Prior/concurrent clinical study experience:
- Participation in any other clinical study that included drug treatment within at least 4 weeks of screening.
- Other exclusions:
- Involvement in the planning and/or conduct of the study (applies to AstraZeneca and FibroGen staff and/or staff at the study site).
- Patient non-adherence to medications or missing >1 dialysis treatments/month per the Investigator's knowledge.
- Previous randomization in the present study.
- History of alcohol or drug abuse within 2 years prior to randomization.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Research Site
Baotou, 14010
Research Site
Beijing, 100029
Research Site
Beijing, 100044
Research Site
Beijing, 100730
Research Site
Guangzhou, 510180
Research Site
Jinan, 250012
Research Site
Shenyang, 110001
Research Site
Wuhan, 430022
About this study
Official title: ALTAI: An Open-Label, Randomized, Active-Controlled, Parallel Design, Multicenter Phase IV Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
This is a Phase IV, randomized, active-controlled, open-label, parallel design, multicenter prospective study to evaluate the effect of roxadustat versus rHuEPO treatment on the gastrointestinal (GI) iron absorption in patients with anemia of Stage 4 and Stage 5 CKD.
Read the detailed description
This is an open-label study, after eligibility confirmation patients will be randomized in a 1:1 ratio to either roxadustat or rHuEPO arms for 2 weeks.
The study will enroll eligible dialysis and non-dialysis patients ≥18 years of age, who have anemia of CKD, and are either dialysis-dependent (DD) and on a stable dose of rHuEPO within 4 weeks prior to screening, or are non-dialysis-dependent (NDD) and are being treated with rHuEPO (ie, on a stable dose of rHuEPO within 4 weeks prior to screening), or are rHuEPO -naïve at the time of screening.
Each patient will be contacted before the first Screening Visit (Visit 1) for the symptoms of coronavirus disease of 2019 (COVID-19) and for any contact with COVID-19 positive person within the past 14 days.
For each patient, the duration of participation in the study will be approximately 8 to 9 weeks divided into 3 periods: Screening Period (approximately 2-3 weeks); Treatment Period (2 weeks) and Post-Treatment Follow-up Period (4 weeks).
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Roxadustat, rHuEPO
- Keywords
- Recombinant Human Erythropoietin, Roxadustat, Coronavirus disease of 2019, Chronic kidney disease, Anemia
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
The starting dose of roxadustat will be in accordance with the China package insert, and will depend on the body weight of the patient: 100 mg (45 to < 60 kg) or 120 mg (≥ 60 kg) in patients on dialysis; 70 mg (40 to < 60 kg) or 100 mg (≥ 60 kg) in non-dialysis patients.
rHuEPODrug
The starting dose of rHuEPO will be in accordance to the dosage approved in rHuEPO China package insert (patients on weekly dose of 6000 IU [dosing will BIW], and patients on weekly dose of >6000 IU [dosing will TIW]) and on patient's haemoglobin levels.
| Study group | Role | What they receive |
|---|---|---|
| Roxadustat | Experimental | Patients will receive oral dose of roxadustat three times a week (TIW) for 2- weeks during treatment period. Receives: Drug: Roxadustat |
| rHuEPO | Active comparator | Patients will receive uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2- weeks during treatment period. Receives: Drug: rHuEPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours)
The main effect of roxadustat versus rHuEPO on GI iron absorption was evaluated.
Measured: From Baseline (Day 1) to Day 15
Secondary outcomes (9)
Difference From Baseline to Day 15 in Area Under Curve (AUC) of Iron Absorption (0-3 Hours)
The effect and interaction with key baseline variables of roxadustat versus rHuEPO on iron absorption was assessed.
Measured: From Baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Serum Iron
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: serum iron was assessed.
Measured: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Ferritin
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Ferritin was assessed.
Measured: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Total Iron Binding Capacity (TIBC)
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TIBC was assessed.
Measured: From baseline (Day 1) to Day 15
Relative Difference From Baseline to Day 15 in Transferrin Saturation (TSAT)
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TSAT (fraction of TIBC) was assessed.
Measured: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Transferrin
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Transferrin was assessed.
Measured: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Soluble Transferrin Receptor
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Soluble transferrin receptor was assessed.
Measured: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Hepcidin
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of Hepcidin was assessed.
Measured: From baseline (Day 1) to Day 15
Number of Subjects With Adverse Events (AEs)
AEs as variables of safety was assessed.
Measured: From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start22 Feb 2021
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Li Xuemei, Principal investigator, Peking Union Medical College Hospital (Dongdan campus) No.1 Shuaifuyuan Wangfujing Dongcheng District Beijing, China 100730
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655027
- Sponsor's protocol ID
- D5741C00002
- Status last verified
- Apr 2024
- First submitted
- 3 Dec 2020
- Last updated
- 22 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Wu H, Cheng H, Wang C, Yao L, Qin S, Zuo L, Hu Z, Zhang C, Wu Y, Hofherr A, Mohan K, Rush S, Li X. Roxadustat and Oral Iron Absorption in Chinese Patients with Anemia of Chronic Kidney Disease: A Randomized, Open-Label, Phase 4 Study (ALTAI). Adv Ther. 2024 Mar;41(3):1168-1183. doi: 10.1007/s12325-023-02741-5. Epub 2024 Jan 27.
PubMed 38280066
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALTAI: An Open-Label, Randomized, Active-Controlled, Parallel Design, Multicenter Phase IV Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT04655027
- Acronym / sponsor ID
- D5741C00002
- Conditions
- Anemia of Chronic Kidney Disease
- Keywords
- Recombinant Human Erythropoietin, Roxadustat, Coronavirus disease of 2019, Chronic kidney disease, Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Posted 22 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IV, randomized, active-controlled, open-label, parallel design, multicenter prospective study to evaluate the effect of roxadustat versus rHuEPO treatment on the gastrointestinal (GI) iron absorption in patients with anemia of Stage 4 and Stage 5 CKD.
Detailed description
This is an open-label study, after eligibility confirmation patients will be randomized in a 1:1 ratio to either roxadustat or rHuEPO arms for 2 weeks.
The study will enroll eligible dialysis and non-dialysis patients ≥18 years of age, who have anemia of CKD, and are either dialysis-dependent (DD) and on a stable dose of rHuEPO within 4 weeks prior to screening, or are non-dialysis-dependent (NDD) and are being treated with rHuEPO (ie, on a stable dose of rHuEPO within 4 weeks prior to screening), or are rHuEPO -naïve at the time of screening.
Each patient will be contacted before the first Screening Visit (Visit 1) for the symptoms of coronavirus disease of 2019 (COVID-19) and for any contact with COVID-19 positive person within the past 14 days.
For each patient, the duration of participation in the study will be approximately 8 to 9 weeks divided into 3 periods: Screening Period (approximately 2-3 weeks); Treatment Period (2 weeks) and Post-Treatment Follow-up Period (4 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roxadustat | Experimental | Drug: RoxadustatPatients will receive oral dose of roxadustat three times a week (TIW) for 2- weeks during treatment period. |
| rHuEPO | Active comparator | Drug: rHuEPOPatients will receive uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2- weeks during treatment period. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Informed consent • Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses.
- Type of patient and disease characteristics
- At Visit 1 prior to screening
- Patients receiving hemodialysis (HD) or peritoneal dialysis (PD) for treatment of end-stage renal disease (ESRD) for at least 12 weeks. Patients treated with HD must have access consisting of an arteriovenous (AV) fistula, AV graft, or tunneled (permanent) catheter. Patients on PD must have a functioning PD catheter in place.
- Hemodialysis patients should be on 3x/week dialysis with evidence of achievement of adequate dialysis as defined by standardized Kt/V ≥2.1 in HD, and total (renal + PD) weekly Kt/V ≥1.7 in PD documented twice during the 16 weeks preceding screening for the study.
Key exclusion criteria (36 listed)
- Medical conditions
- New York Heart Association Class III or IV congestive heart failure (CHF) at screening.
- Acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
- History of severe, chronic, end-stage, or uncontrolled autoimmune liver disease with ALT 3 x ULN, or AST > 3 × ULN, or total bilirubin > 1.5 × ULN.
- Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red-cell aplasia or other known causes for anemia other than CKD.
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 |
|---|---|---|
| RoxadustatThe starting dose of roxadustat will be in accordance with the China package insert, and will depend on the body weight of the patient: 100 mg (45 to < 60 kg) or 120 mg (≥ 60 kg) in patients on dialysis; 70 mg (40 to < 60 kg) or 100 mg (≥ 60 kg) in non-dialysis patients. | Drug | Roxadustat |
| rHuEPOThe starting dose of rHuEPO will be in accordance to the dosage approved in rHuEPO China package insert (patients on weekly dose of 6000 IU [dosing will BIW], and patients on weekly dose of >6000 IU [dosing will TIW]) and on patient's haemoglobin levels. | Drug | rHuEPO |
Primary outcome
Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours)
Time frame: From Baseline (Day 1) to Day 15
The main effect of roxadustat versus rHuEPO on GI iron absorption was evaluated.
9 secondary outcomes
Difference From Baseline to Day 15 in Area Under Curve (AUC) of Iron Absorption (0-3 Hours)
Time frame: From Baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Serum Iron
Time frame: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Ferritin
Time frame: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Total Iron Binding Capacity (TIBC)
Time frame: From baseline (Day 1) to Day 15
Relative Difference From Baseline to Day 15 in Transferrin Saturation (TSAT)
Time frame: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Transferrin
Time frame: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Soluble Transferrin Receptor
Time frame: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Hepcidin
Time frame: From baseline (Day 1) to Day 15
Number of Subjects With Adverse Events (AEs)
Time frame: From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38280066Wu H, Cheng H, Wang C, Yao L, Qin S, Zuo L, Hu Z, Zhang C, Wu Y, Hofherr A, Mohan K, Rush S, Li X. Roxadustat and Oral Iron Absorption in Chinese Patients with Anemia of Chronic Kidney Disease: A Randomized, Open-Label, Phase 4 Study (ALTAI). Adv Ther. 2024 Mar;41(3):1168-1183. doi: 10.1007/s12325-023-02741-5. Epub 2024 Jan 27.
- redacted Statistical Analysis PlanLink provided by the sponsor.
- redacted Clinical Study ProtocolLink provided by the sponsor.
- redacted Clinical Study Report SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Li Xuemei principal investigator
Peking Union Medical College Hospital (Dongdan campus) No.1 Shuaifuyuan Wangfujing Dongcheng District Beijing, China 100730
8 sites 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 and rHuEPO in people with Anemia of Chronic Kidney Disease, run by AstraZeneca at 8 sites 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 28 inclusion and 36 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 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Yes. Results are posted in the registry (first posted 22 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) (time frame: From Baseline (Day 1) to Day 15). 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 NCT04655027, 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 22 Apr 2024.