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This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period.
There are 3 study periods:
Part 1: Correction/Conversion Period (Weeks 1-20)
Part 2: Hemoglobin (Hb) Maintenance Period (Weeks 21-36)
Approximately 102 erythropoiesis stimulating agents (ESA)-naïve participants and 204 ESA-treated participants will be enrolled and randomized respectively in a 1:1 ratio to receive roxadustat at one of 2 starting doses as below:
After 20 weeks of treatment, all eligible participants whose last 2 Hb levels ≥105 grams (g)/liter (L) and change in Hb over the most recent 4 weeks is > - 10 g/L will switch to receive roxadustat for another 16 weeks to evaluate the efficacy and safety of new dosing regimens.
At the end of Week 36, all participants will discontinue roxadustat and enter a 4-week Follow-up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: ESA-Naïve Participants - Low Weight Based Dosing | Experimental | ESA-naïve participants will receive roxadustat 70 mg TIW for body weight 45 to <60 kg or 100 mg TIW for body weight ≥60 kg. |
|
| Part 1: ESA-Naïve Participants - Standard Weight Based Dosing | Experimental | ESA naïve participants will receive roxadustat 100 mg TIW for body weight 45 to <60 kg or 120 mg TIW for body weight ≥60 kg. |
|
| Part 1: ESA-Treated Participants - Low Weight Based Dosing | Experimental | ESA-treated participants will receive roxadustat 70 mg TIW for body weight 45 to <60 kg or 100 mg TIW for body weight ≥60 kg. |
|
| Part 1: ESA-Treated Participants - Standard Weight Based Dosing | Experimental | ESA treated participants will receive roxadustat 100 mg TIW for body weight 45 to <60 kg or 120 mg TIW for body weight ≥60 kg. |
|
| Part 2: Roxadustat QW | Experimental | Participants will receive roxadustat once a week (QW). Roxadustat dose will be 2-dose step increase from originally planned week 21 TIW per dose amount. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roxadustat | Drug | Roxadustat will be dosed orally per dose and schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks | Weeks 1 to 20 | |
| Part 1 (ESA Treated): Percentage of Participants who Achieved Mean Hb ≥100 g/L Averaged Over Weeks 17 to 21 Visits | Weeks 17 to 21 | |
| Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits | Weeks 33 to 37 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits | Baseline, Weeks 17 to 21 | |
| Part 1 (ESA-Naïve): Percentage of Participants With Mean Hb (Averaged Weeks 17 to 21 Visits) ≥100 g/L | Weeks 17 to 21 |
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Inclusion Criteria:
1. CKD with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Hefei | Anhui | 230601 | China | ||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36005278 | Derived | Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2. |
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|
| Part 2: Roxadustat BIW | Experimental | Participants will receive roxadustat twice a week (BIW). Roxadustat dose will be 1-dose step increase from originally planned week 21 TIW per dose amount. |
|
| Part 2: Roxadustat TIW | Experimental | Participants will receive roxadustat TIW. Roxadustat dose will continue per dose adjustment guideline. |
|
|
| Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L | Weeks 33 to 37 |
| Lanzhou |
| Gansu |
| 730030 |
| China |
| Investigational Site | Guangzhou | Guangdong | 510515 | China |
| Investigational Site | Shenzhen | Guangdong | 518020 | China |
| Investigational Site | Nanning | Guangxi | 530021 | China |
| Investigational Site | Zhengzhou | Henan | 450052 | China |
| Investigational Site | Wuhan | Hubei | 430060 | China |
| Investigational Site | Changsha | Hunan | 410008 | China |
| Investigational Site | Baotou | Inner Mongolia | 014010 | China |
| Investigational Site | Nanjing | Jiangsu | 210009 | China |
| Investigational Site | Nanchang | Jiangxi | 330006 | China |
| Investigational Site | Changchun | Jilin | 130021 | China |
| Investigational Site | Shenyang | Liaoning | 110004 | China |
| Investigational Site | Shenyang | Liaoning | 110122 | China |
| Investigational Site | Taiyuan | Shanxi | 030001 | China |
| Investigational Site | Xi’an | Shanxi | 710004 | China |
| Investigational Site | Xi’an | Shanxi | 710061 | China |
| Investigational Site | Chengdu | Sichuan | 610041 | China |
| Investigational Site | Chengdu | Sichuan | 610072 | China |
| Investigational Site | Hangzhou | Zhejiang | 310003 | China |
| Investigational Site | Beijing | 100044 | China |
| Investigational Site | Beijing | 100191 | China |
| Investigational Site | Beijing | 100730 | China |
| Investigational Site | Shanghai | 200025 | China |
| Investigational Site | Tianjin | 300052 | China |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C584543 | roxadustat |
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