Health Condition 1: D631- Anemia in chronic kidney disease
Conditions
Interventions
Intervention1: Ferric pyrophosphate citrate solution: Ferric pyrophosphate citrate solution will be administered via dialysate during each dialysis session (3 times per week)for 42 weeks.
Control Inte
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult CKD stage 5 patients of either gender of age ââ?°Â¥ 18 years undergoing chronic hemodialysis at least 3 times per week for at least 3 months prior to screening, and expected to remain on this schedule and able to complete the duration of the study. 2. Patients on minimally adequate measured dialysis dose prior to randomization; defined as urea reduction ratio greater than equal to 65 percentage URR is equal to 1 minus Ureapost-HD divided by Ureapre-HD multiplied by 100, or single-pool Kt by V dialyzer clearance of urea multiplied by dialysis time, divided by patientââ?¬•s total body water greater than equal to 1.2, or KIDt by V online dialyzer clearance measured using ionic dialysance multiplied by dialysis time, divided by patients total body water greater than equal to 1.2. 3. Dialyzer blood flow rate (QB) prior to randomization ââ?°Â¥ 250 mL/min. 4. Must be willing and able to provide written informed consent directly or through their legally authorized representative (LAR). 5. Received IV iron therapy between 6 months and 2 weeks prior to randomization in order to replace iron losses resulting from hemodialysis procedure. 6. Agree to be ââ?¬Ë?without Oral or IV iron supplementationââ?¬• from 2 weeks prior to randomization until end-of-treatment (EOT) and ââ?¬Ë?no change in ESA doseââ?¬• from randomization until EOT by the patient/LAR. 7. Mean screening pre-dialysis Hb ââ?°Â¥ 9.5 to ââ?°Â¤ 11.5 grams per deciliter (g/dL) (i.e., average Hb values of Week -2 & Week -1) at randomization. 8. Mean screening pre-dialysis serum (S.) ferritin ââ?°Â¥ 200 to 9. Mean screening pre-dialysis Transferrin Saturation (TSAT) ââ?°Â¥ 20% to ââ?°Â¤40% (i.e., average TSAT values of Week -2 & Week -1) at randomization. 10. If being administered erythropoietin stimulating agent (ESA) [epoetin, darbepoetin, or continuous erythropoietin receptor activator (CERA)], the patient should be on stable dose of ESA without change in the route of administration for at least 4 weeks prior to screening. [Stable dose of ESA is defined as the dose change of 11. Vascular access for dialysis that will be used upon enrollment with stable function in the judgment of the Investigator. 12. Undergoing dialysis only using an arteriovenous (AV) fistula, graft, or tunneled catheter. 13. Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period. If currently abstinent, the patients must agree to use a double barrier method as described above if she becomes sexually active during the study period. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation. [Note: Women with chi
Exclusion criteria
Exclusion criteria: 1. Patient who has living kidney donor identified or living-donor kidney transplant scheduled. 2. Vascular access for dialysis with non-tunneled catheter. 3. Patients who are anticipated to be unable to complete the entire study (e.g., due to concurrent disease) based on Investigatorââ?¬•s clinical judgment. 4. Received IV or oral iron therapy within 2 weeks prior to the randomization. 5. Known causes of anemia other than renal failure and HD (e.g., sickle cell disease, thalassemia, pure red cell aplasia, hemolytic anemia, myelodysplastic syndrome, etc.). 6. Known active bleeding from any site other than AV fistula or graft (e.g., gastrointestinal, hemorrhoidal, nasal, pulmonary, etc.). 7. The patient has any current febrile illness (e.g., oral temperature ââ?°Â¥100.4Ã?°F/38.0Ã?°C). The patient may subsequently become eligible at least 1 week after resolution of the illness. 8. Planned elective surgery during the study period (from screening to end of the study). 9. Patients with known cirrhosis of liver (based on previously documented histological criteria) or Patients with decompensated liver cirrhosis based on clinical criteria (e.g., presence of ascites, esophageal varices, spider nevi, or history/presence of encephalopathy. 10. RBC or whole blood transfusion within 8 weeks prior to randomization. 11. Patients with serum vitamin B12 and/or serum folic acid deficiency at screening (Note: Retest for serum Vitamin B12 and/or serum folic acid acceptable during screening). 12. Patients having human immunodeficiency virus - human immunodeficiency virus, acquired immunodeficiency syndrome (HIV-AIDS), hepatitis B, C, and Occult /latent tuberculosis (TB) at Screening. 13. Hospitalization in previous three months (except for vascular access surgery) that, in the opinion of the Investigator, confers a significant risk of hospitalization during the course of this study. 14. Evidence of any current malignancy except cancers of the skin (either by previously documented laboratory/histological reports or by Investigatorââ?¬•s clinical judgment/suspicion). 15. Known ongoing inflammatory disorder (other than CKD), such as systemic lupus erythematosus, rheumatoid arthritis, or other collagen-vascular disease. 16. Known coagulation disorder. 17. Known active bacterial, tuberculosis, fungal, viral, or parasitic infection requiring anti-microbial therapy or anticipated to require anti-microbial therapy during the patientââ?¬•s participation in this study. 18. Patients with tuberculosis requiring prophylactic treatment with anti-tubercular drug(s) that overlaps with the patientââ?¬•s participation in this study. 19. Participation in a study of an investigational drug or device within 30 days prior to enrolment in this study, and agree not to participate in any other clinical trial during the study period and up to 30 days after completion of the trial. 20. Patient with a clinically significant condition that in the Investigatorââ?¬•s opinion precludes the patientââ?¬•s participation in the study or interferes with the interpretation of the study results. 21. History of alcohol or any substance abuse within the last 1 year prior to screening as per Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria. 22. Pregnancy or intention to become pregnant be
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in hemoglobin (Hb) from baseline to End-of-Treatment (EOT). Timepoint: baseline to End-of-Treatment (EOT). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in pre-dialysis serum ferritin 2. Mean change from pre-dialysis to post-dialysis in serum iron and TSAT over the entire randomized treatment period 3. Mean change and mean percentage change in the pre-dialysis reticulocyte hemoglobin content (CHr), serum iron, TSAT, UIBC, and TIBC. 4. The proportion of patients who meet each protocol-mandated anemia management (PMAM) criterion 5. The proportion of completers with Hb 12.5 g/d 6. The proportion of completers with Hb 10 g/dL 7. The proportion of completers with ferritin 100 Ã?µg/L 8. Time to achieve end-of-treatment criteria 9. Mean change in High-sensitive C-reactive protein (hs-CRP) 10. Mean change in Interleukin (IL) -6 11. Mean change in hepcidin 12. Proportion of patients receiving RBC or whole blood transfusion 13. Number of units RBC or whole blood transfusion 14. Change in quality-of-life (QoL) score (using dialysis recovery time and/or KDQOL v. 1.3)Timepoint: 1. From baseline to EOT 2. From baseline to EOT 3. From baseline to EOT 4. From baseline to EOT 5. EOT 6. EOT 7. EOT 8. From baseline to EOT 9. From baseline to EOT 10. From baseline to EOT 11. From baseline to EOT 12. From baseline to EOT 13. From baseline to EOT 14. From baseline to EOT | — |
Countries
India
Contacts
Public ContactRajesh Gaikwad
Sun Pharma Laboratories Limited
Outcome results
None listed