| CTRI Number |
CTRI/2021/07/034812 [Registered on: 13/07/2021] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To check the
efficacy, safety and tolerability of Sucroferric Oxyhydroxide Chewable Tablet
in patients with chronic kidney disease. |
|
Scientific Title of Study
|
An open label, multicentric, non-comparative clinical study to investigate the
efficacy, safety and tolerability of Sucroferric Oxyhydroxide Chewable Tablet
(Dynultaâ„¢) in patients with chronic kidney disease on dialysis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECTS/20/002, Version no. 01, Date: 14 Dec 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milan Satia |
| Designation |
Chief Executive Officer |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milan Satia |
| Designation |
Chief Executive Officer |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milan Satia |
| Designation |
Chief Executive Officer |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
|
Source of Monetary or Material Support
|
| Ethicare Clinical Trial Services
|
|
|
Primary Sponsor
|
| Name |
Emcure Pharmaceuticals Ltd India |
| Address |
Plot No. P2, ITBT Park, MIDC, Phase II,
Hinjewadi, Pune 411057, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Srinivas |
Dr.Sanjay’s Center for Kidney and Diabetes, Karnataka |
Dr.Sanjay’sCenter for Kidney and Diabetes, 357/B, opposite RR Gold Palace, BB Road, Near Santhe Circle Yelahanka old Town, Bengalore-560064, Karnataka Bangalore Karnataka
Bangalore
KARNATAKA |
91702247227
sanjay.cr@gmail.com |
| Dr Niranjan M R |
K R Hospital, Mysore Medical College and Research |
Room Number 05 Ground floor, next to Ortho Department, KR Hospital, Mysore medical College & Research Institute, Irwin Rd, DevrajMohalla, Mysore, Karnataka 570001
Mysore
KARNATAKA |
9448672501
drniranjanmr@gmail.com |
| DrVibhanshu Gupta |
Pushpanjali Hospital & Research Centre |
Pushpanjali Hospital & Research Centre Pvt. Ltd. Pushpanjali Palace, Delhi Gate Agra-282002
Agra
UTTAR PRADESH |
88087836967
vibhanshug@rediffmail.com |
| Dr A K Bhalla |
Sir Ganga Ram Hospital. |
Department of Clinical Research, Nephrology, Room #1297, Dialysis unit, SWB IInd floor, Sir Ganga Ram Hospital, Old Rajindera Nagar, New Delhi 110060
New Delhi
DELHI |
9811047377
bhallaak@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Dr. Sanjay’s Hospital Ethics Committee |
Approved |
| Institutional Ethics Committee, Mysore Medical College |
Approved |
| Pushpanjali Hospital Ethics Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Sucroferric Oxyhydroxide Chewable Tablet (Dynultaâ„¢) |
DynultaTM contains 500 mg iron (equivalent to 2500 mg
sucroferric oxyhydroxide). One tablet 3 times a day for 12 weeks. Dose increase or decrease of one tablet per day are permitted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female adult subjects (aged ≥18 years at time of consent) receiving maintenance haemodialysis (HD) for at least 12 weeks prior to screening.
2. Subjects with a history of hyperphosphataemia (HP).
3. Subjects with serum phosphorus levels >5.5 mg/dl (>1.78 mmol/l) at screening.
4. Subjects with the ability to understand the requirements of the study and abide by the study restrictions, and who agree to return for the required assessment.
5. Subject willing to provide and sign written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Subjects with intact parathyroid hormone (iPTH) levels >800 ng/l (>800 pg/ml or 88 pmol/l) at screening.
2. Subjects with planned or expected parathyroidectomy within the next 6 months.
3. Subjects with serum total calcium >10.5 mg/dl (>2.6 mmol/l) or <7.6 mg/dl (1.9 mmol/l) at screening.
4. Subjects with:
Subjects with:
Any history of major gastrointestinal (GI) surgery.
Clinically significant, active GI disorders (e.g., active peptic ulcer, Crohns disease, colitis ulcerative, irritable bowel syndrome, intestinal motility disorder (symptomatic gastroparesis (during treatment or untreated), intestinal obstruction, moderate/severe constipation (including persistent symptoms with regular use of laxatives or enemas and limitations in activities of daily living), intestinal pseudo-obstruction, megacolon, mechanical obstruction)) or any GI disorders under medical treatment.
Clinically significant, active hepatic disorders or any hepatic disorder
under medical treatment.
5. Subjects currently with:
Swallowing difficulties/dysphagia.
Estimated life expectancy of less than 12 months
Anticipated renal transplantation during study participation.
6. Subjects with a history of Haemochromatosis or other iron accumulation disorders that might lead to iron overload.
7. Subjects with raised alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of the normal range at
screening.
8. Subject taking any prohibited medication which cannot be stopped at
least one week before study treatment start. Prohibited medications include: oral calcium supplements, any drugs / agents having a phosphate binding action that contain aluminium, magnesium or calcium (apart from
hyperkalaemia drugs) phosphate binders in addition to sevelamer carbonate), nicotinamide, oral iron products, oral vitamins containing iron and other oral iron containing supplement.
9. Subject has known hypersensitivity and/or intolerance to any of the study products to be administered.
10. Subject has previously been randomized into this study.
11. Subject is currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or is receiving other investigational agent.
12. Subjects who are pregnant (e.g., positive human chorionic gonadotropin test) or breastfeeding.
13. Subjects of childbearing potential, not using adequate contraceptive
precautions must agree to use a highly effective method of birth control
during the study and for 1 month after the last dose of study medication.
14. Subject has a history of drug or alcohol abuse within 2 years.
15. Subject has a significant medical conditions or anticipated need for major
surgery during the study, which may be
associated with increased risk to the subject, may be associated with increased risk to the subject, may be associated with increased risk to the subject. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate efficacy of Sucroferric Oxyhydroxide Chewable Tablet by Change in serum
phosphorus level from baseline to each visit |
93 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Frequency of AEs determined by seriousness, severity and relatedness to
study drugs.
Change from baseline in CBC, bio-chemistry (SGOT, SGPT and glucose),
and serum calcium serum iPTH (intact parathyroid hormone) at week 12. |
93 days |
|
|
Target Sample Size
|
Total Sample Size="117"
Sample Size from India="117"
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
27/09/2021 |
| Date of Study Completion (India) |
24/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An open label, multicentric, non-comparative clinical phase IV study to investigate the efficacy, safety and tolerability of Sucroferric Oxyhydroxide Chewable Tablet (Dynultaâ„¢) in patients with chronic hemo dialysis (male and female) with chronic kidney disease. Total 117 subjects who are fulfilling inclusion criteria will be enrolled in the study. Subjects with a history of hyperphosphataemia (HP) will be selected for the study.
Screened subjects will be evaluated and the eligible subjects will be enrolled in the study. The subjects will be followed up for day 28, 56 and 84. The vital signs (blood pressure, pulse rate, body temperature and respiratory rate) will be recorded at
the time of screening visit and during all study visits throughout the study. The primary endpoint assessment will be efficacy of Sucroferric Oxyhydroxide Chewable Tablet by change in serum phosphorus level from baseline to each visit. The secondary assessment endpoint include change from baseline in CBC, bio-chemistry (SGOT, SGPT and glucose),
and serum calcium serum iPTH (intact parathyroid hormone) at week 12. |