CTRI/2024/10/076004 [Registered on: 28/10/2024] Trial Registered Prospectively
Last Modified On:
20/01/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Evaluate the bioequivalence with the clinical endpoint of ferric citrate tablet in patients with chronic kidney disease not on dialysis (CKD-NDD)
Scientific Title of Study
A Randomized, multicenter, double-blind, parallel-group, three-arm, placebo-controlled study to evaluate the bioequivalence with the clinical endpoint of ferric citrate tablet of Mylan Inc versus Auryxia® (ferric citrate tablet, Keryx Biopharmaceuticals Inc) in patients with chronic kidney disease not on dialysis
(CKD-NDD).
All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar - 751019, Odisha, India
Khordha ORISSA
9626801175
nephro_sandip@aiimsbhubaneshwar.edu.in
Dr Ajaypal Singh
Apex Hospital Pvt Ltd
S P 4 & 6 Malviya Industrial Area, Malviya Nagar Jaipur - 302017, Rajasthan, India Clinical Trial Department at Basement of Academic Block
Jaipur RAJASTHAN
Opp. DRM office, Nr. Chamunda Bridge, Naroda road, Ahmedabad-380025, Gujarat, India
Room No 106, First Floor, GCS Hospital & Special OPD
Ahmadabad GUJARAT
8141584080
ashir19989@gmail.com
Dr Nageswararao Charukupalli
Govt. Siddhartha Medical College
Govt. Siddhartha Medical College, Ring Road, Gunadala, Vijayawada - 520008, Andhra Pradesh, India Krishna ANDHRA PRADESH
9494475996
drcnr9@gmail.com
Dr Saritha Suryadevara
Help Hospital Pvt Ltd
Department of Clinical Research, Room #201, 1st Floor, Block B, D. No: 27-29-23, Behind Victoria Museum, M. G. Road, Governor Pet, Vijayawada - 520002, Andhra Pradesh, India
Krishna ANDHRA PRADESH
8277082271
suryadevara47@gmail.com
Dr Atanu Pal
IPGME & R and SSKM Hospital
Department of Nephrology, IPGME & R and SSKM Hospital, 244, AJC Bose Road, Kolkata - 700020, West Bengal, India
Kolkata WEST BENGAL
9038080051
dratanup@gmail.com
Dr Niranjan M R
K R Hospital, Mysore Medical College Hospital and Research Institute
2nd Floor, Old Jayadeva Building, Irwin Road, Mysore - 570001, Karnataka, India
Mysore KARNATAKA
9448672501
drniranjanmr@gmail.com
Dr Sunil R
KIMS Hospital & Research Centre
Dept of Nephrology, 1st Floor, B-Block, Kempegowda Institute of Medical Sciences Hospital and Research Centre, KR Road, VV Puram, Banglore-560004, Karnataka, India Bangalore KARNATAKA
9663408608
srnephro@gmail.com
Dr Prakash Khetan
KIMS Kingsway Hospitals
5th floor Research Department, 44, Parwana Bharan, Kingsway, Nagpur - 440001, Maharashtra, India
Nagpur MAHARASHTRA
9823071748
prakash.khetan@kimskingsway.com
Dr Rokade Mahesh Shivaji
MAEERs Vishwaraj Hospital
MAEERs Vishwaraj Hospital, Loni-Kalbhor, Pune - 412201, Maharashtra, India
Pune MAHARASHTRA
9657575900
drmaheshsr@yahoo.co.in
Dr R Hemachandar
Mahatma Gandhi Medical College & Research Institute
Department of Nephrology, 1 Floor-Hospital Block, No.45, Pondy - Cuddalore ECR Main Road, Pillaiyarkuppam, Pondicherry – 607402, India
Pondicherry PONDICHERRY
7667519804
hemachandarr@gmail.com
Dr Joshi Harshal kumar Kamleshbhai
Rhythm Heart Institute
Department of Nephrology, Near Siddharth Bungalows Sama-Savli Road, Vadodara 390022, Gujarat, India Vadodara GUJARAT
9427611847
harshal11joshi@gmail.com
Dr Pavan Wakhare Shripati
Saikrupa Hospital
A - Wing, Second Floor, Saikrupa Hospital, Renuka Corner, Tapkir Chowk, Thergaon, Pune - 411033, Maharashtra, India
Pune MAHARASHTRA
7719016069
pavan.wakhare@gmail.com
Dr Vivek Ruhela
Shri Mahant Indiresh Hospital
Ground Floor, Nephrology OPD, South Block, Shri Guru Ram Rai Institute of Medical and Health Sciences And Shri Mahant Indiresh Hospital, Patel Nagar, Dehradun - 248001, Uttarakhand, India
Dehradun UTTARANCHAL
9721104868
vivekruhela@yahoo.com
Dr Mahendra Mulani
Shubham Multispecialty Hospital
ABC Complex, Rabari Colony Char Rasta, N. H. No. 8, Amraiwadi, Ahmedabad - 380026, Gujarat, India Ahmadabad GUJARAT
9879232382
mulani.mahendra@gmail.com
Dr Waghulde Jayesh Prabhakar
Signus Hospital
5th Floor, Atlanta Shoppers, Pathardi Road, Pathardi Phata, Nashik - 422010, Maharashtra, India Nashik MAHARASHTRA
9922251176
jayeshpwaghulde@gmail.com
Dr Atul Gogia
Sir Ganga Ram Hospital
Sir Ganga Ram Hospital, Sir Ganga Ram Hospital Marg, Rajinder Nagar - 110060, New Delhi, India New Delhi DELHI
9891003450
atulgogia@yahoo.com
Dr Dhokare Aniruddha Shantaram
Supe Heart & Diabetes Hospital and Research Centre
1st Floor, Supe Heart & Diabetes Hospital and Research Centre, Opp. Adhar Asharam, near Rungta School, Gharpure Ghat, Ashok Stambh, Nashik - 422002, Maharashtra, India
Nashik MAHARASHTRA
8286349760
dr.aniruddha19@gmail.com
Dr Pandya Aashay Rajesh
V S General Hospital
V S General Hospital, Paldi Road, Ellis Bridge, Ahmedabad-380006, Gujarat
Ahmadabad GUJARAT
VMH Healthcare & Research Centre, LLP, 3rd Floor OPD-5, Velocity Business hub, near Madhuvan Circle, L.P. Savani Road, Surat - 395009, Gujarat, India Surat GUJARAT
The subjects will receive study drug orally, three times daily with meals for 4 weeks (i.e. from Day 1 to Day 28 day in the study).
Intervention
Ferric citrate 1 g tablet (each tablet equals to 210 mg elemental iron)
The subjects will receive study drug orally, three times daily with meals for 4 weeks (i.e. from Day 1 to Day 28 day in the study).
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or non-pregnant, non-lactating female participants aged greater than 18 and less than 65 years with stage 3-5 chronic kidney disease not on dialysis (CKD-NDD)
2. Individuals will be considered suitable for treatment with ferric citrate based on Investigators clinical judgement.
3. Individuals with estimated glomerular filtration rate (eGFR) less than 60 mL/min, with Hb ≥9.0 g/dL and ≤12 g/dL, serum ferritin ≤300 ng/mL and percentage transferrin saturation (TSAT) ≤30 percentage at screening.
4. Individuals with body weight ≥50 kg at screening and randomization visit with body mass index (BMI) of 18.5 - 30.0 kg/m2 at the time of screening.
5. Individuals with adequate hematopoietic and liver function tests at screening as per Investigators judgement.
6. Female individuals should have been postmenopausal for at least 1 year, or surgically sterilized via hysterectomy, bilateral oophorectomy; or practicing an acceptable form of birth control
ExclusionCriteria
Details
1. Serum phosphorus level at screening less than 3.5 mg/dL.
2. Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to screening.
3. Acute renal insufficiency or requirement for dialysis within 12 weeks prior to randomization.
4. Blood transfusion or intravenous (IV) iron administration or ESA administration within 4 weeks prior to screening.
5. Infection requiring oral or IV antibiotic use within 2 weeks prior to randomization.
6. Anemia other than iron deficiency or chronic kidney disease (CKD).
7. Known allergic reactions to oral or IV iron treatment or any of the excipients.
8. Liver enzymes [aspartate aminotransferase (AST) or alanine aminotransferase (ALT)] greater than 3 times upper limit normal (ULN) at Screening.
9. History of iron overload syndromes, such as hemochromatosis.
10. Previous intolerance to oral ferric citrate.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of participants with treatment success [where success is defined as an increase in Hb of ≥1.0 g/dL from baseline at the end of Week 4 (after 28 days of treatment)].
Day 1 to Day 29 + 2 days [End of Study (EOS)]
Secondary Outcome
Outcome
TimePoints
Mean change in serum ferritin from baseline to Week 4 (after 28 days of treatment)
a. Mean change in Percentage transferrin saturation (TSAT) from baseline to Week 4 (after 28 days of treatment)
b. Incidence of adverse events throughout the study.
Safety will be assessed throughout the study,
i.e., from Day 1 to Day 43 ±3 days [End of Study (EOS)]
Target Sample Size
Total Sample Size="423" Sample Size from India="423" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
15/11/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="7" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Randomized, multicenter, double-blind, parallel-group, three-arm, placebo-controlled study to evaluate the bioequivalence with the clinical endpoint of ferric citrate tablet of Mylan Inc. versus Auryxia® (ferric citrate tablet, Keryx Biopharmaceuticals Inc.) in patients with chronic kidney disease not on dialysis (CKD-NDD)
Participants will be enrolled in the study after successfully completing screening activities between Day -14 to Day -1. Approximately 423 participants with CKD-NDD fulfilling the eligibility criteria will be randomized in 1:1:1 ratio to receive either Mylan’s Ferric citrate tablet (n = 141), RLD - Auryxia ferric citrate tablet (n = 141) or Placebo (n = 141). Randomized participants will be treated with ferric citrate 1 g tablet (each tablet = 210 mg elemental iron) or Placebo, three times daily with meals for 28 days
Following laboratory assessments will be performed during Visit 1 (Screening Visit), Visit 2, Visit 3, Visit 4, Visit 5, and Visit 6. Laboratory assessments done during Screening Visit will be considered for the purpose of determination of eligibility
· 1 Complete blood count- hemoglobin (Hb), hematocrit, total and differential white blood count (WBC), red blood count (RBC), platelet count
·2 Complete chemistry profile including liver function tests (albumin, bilirubin, alanine aminotransferase