To Evaluate the Efficacy and Safety of Ferric Pyrophosphate Citrate Administered via Dialysate to Maintain Hemoglobin Concentration in Chronic Kidney Disease Patients Receiving Hemodialysis (a procedure where a dialysis machine or a dialyzer are used to clean your blood)

Phase 3

Not yet recruiting

• Conditions: Anemia in chronic kidney disease,

• Registration Number: CTRI/2022/06/042974
• Lead Sponsor: Sun Pharma Laboratories Limited

Brief Summary

This study will be a phase 3, multicenter,randomized, single-blind, placebo-controlled, parallel-arm study to evaluate efficacy and safetyof FPC dialysate solution administered via dialysate to maintain Hb concentrations in CKD patientsreceiving HD.

The study willbe conducted at approximately 25-30 numbers of centers in India, havingqualified Investigators. The study will be initiated only after the receipt ofRegulatory and Ethics committee (EC) approval.

Thestudy consists of following days of assessments:

·     **Screening Visit:** (Week -2 to Week -1):Screening

·     **Treatment Period (**Week 1 to Week 42)

Ø  **Study Initiation Visit** (Week 1; 2nd HD session):Randomization, Study drug administration, Baseline parametersassessment

Ø  **On Treatment Visit (**2nd HD session ofWeek1 to 2nd HD session of Week 42): Study drug administration, efficacyand safety parameters assessment

·     **End of Treatment Visit:** 2nd HDsession of Week 42; EOT assessment

·     **End of study visit/ Follow Up period:** FromEOT to 3rd HD session of Week 43; EOS assessment

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-06
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• 1.Adult CKD stage 5 patients of either gender of age ≥ 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 patient’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 ≥ 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 ‘without Oral or IV iron supplementation’ from 2 weeks prior to randomization until end-of-treatment (EOT) and ‘no change in ESA dose’ from randomization until EOT by the patient/LAR.
• 7.Mean screening pre-dialysis Hb ≥ 9.5 to ≤ 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 ≥ 200 to < 1000 micrograms per liter (µg/L) (i.e., average S.
• Ferritin values of Week -2 & Week -1) at randomization.
• 9.Mean screening pre-dialysis Transferrin Saturation (TSAT) ≥ 20% to ≤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 < 35% (i.e., [maximum [max] – minimum [min] dose]/max dose < 0.35)].
• 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 childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal.
• Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age].
• 14.Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period).
• No sperm donation is allowed during the study period.

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 Investigator’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 ≥100.4°F/38.0°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 Investigator’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 patient’s participation in this study. 18.Patients with tuberculosis requiring prophylactic treatment with anti-tubercular drug(s) that overlaps with the patient’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 Investigator’s opinion precludes the patient’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 before completing all study drug treatment. 23.Lactating woman. 24.Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in hemoglobin (Hb) from baseline to End-of-Treatment (EOT).	baseline to End-of-Treatment (EOT).

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (26)

All India Institute of Medical Sciences; 🇮🇳 Nagpur, MAHARASHTRA, India

All India Institute Of Medical Sciences; 🇮🇳 Raipur, CHHATTISGARH, India

Avishkar Dialysis Centre; 🇮🇳 Kantha, GUJARAT, India

Dr. D.Y. Patil Medical College Hospital & Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. M.K Shah Medical College & Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. Sanjay Hospital; 🇮🇳 Bangalore, KARNATAKA, India

G.S.V.M. Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Government Medical College and Hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

Govt. Medical College & Government General hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Ishwar Institute of Health Care; 🇮🇳 Aurangabad, MAHARASHTRA, India

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All India Institute of Medical Sciences

🇮🇳Nagpur, MAHARASHTRA, India

Dr Amol Bhawane

Principal investigator

8800905030

amolbhawane@gmail.com