| CTRI Number |
CTRI/2025/11/098235 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to compare the ability of the drugs ferric citrate and sevelamer carbonate to lower serum phosphate levels in patiets with chronic kidney disease. |
Scientific Title of Study
Modification(s)
|
Randomized controlled trial to compare the efficacy of
ferric citrate with sevelamer carbonate as phosphate binder in
chronic kidney disease |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mitali Gupta |
| Designation |
Post Graduation Student, MD Pharmacology |
| Affiliation |
Dr. Rajendra Prasad Medical College, Tanda |
| Address |
MiGi House, Panah Building,
Near Govt. High School,
Upper Bharari, Shimla
171001
Mitali Gupta,
Plot no 4
Army Colony,
RPGMC Road
Tanda
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
08971026207 |
| Fax |
|
| Email |
mitaligupta2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atal Sood |
| Designation |
Professor and Head, Department of Pharmacology, Tanda. |
| Affiliation |
Dr. Rajendra Prasad Medical College, Tanda |
| Address |
Department of Pharmacology,
Dr Rajendra Prasad Medical College, Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418063191 |
| Fax |
|
| Email |
atalsood7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mitali Gupta |
| Designation |
Post Graduation Student, MD Pharmacology |
| Affiliation |
Dr. Rajendra Prasad Medical College, Tanda |
| Address |
MiGi House, Panah Building,
Near Govt. High School,
Upper Bharari, Shimla
171001
Mitali Gupta,
Plot no 4
Army Colony,
RPGMC Road
Tanda
HIMACHAL PRADESH
171001
India |
| Phone |
08971026207 |
| Fax |
|
| Email |
mitaligupta2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Medical College,Tanda, 176001 |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Medical College, Tanda |
| Address |
Dr Rajendra Prasad Medical College, Tanda, 176001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mitali Gupta |
Dr Rajendra Prasad Medical College, Tanda |
Dr Rajendra Prasad Medical College, Tanda, 176001
Kangra
HIMACHAL PRADESH |
08971026207
mitaligupta2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Dr RPGMC, Tanda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ferric citrate |
Ferric citrate is oral, non-calcium, aluminum-free, ferric iron-based phosphate binder that acts in the GI tract. In the GI tract, it dissociates into ferric ion (Fe+3) and citrate (C6H4O4-) components. Ferric ion combines with multiple phosphate ions and forms a ferric phosphate precipitate which is excreted in the stool leading to decreased absorption of phosphate. The tablet contains 210 mg of ferric iron supplied as 1 g of ferric citrate. In patients of chronic kidney disease, it is administered in the dose of 210 mg two times a day and the dose will be titrated upwards as per change in phosphate levels. |
| Comparator Agent |
sevelamer carbonate |
Sevelamer Caronate is a Synthetic non-absorbable ion-exchange polymer that binds phosphate and inhibits its absorption by the body. In patients of chronic kidney disease, it is administered at a dose of 400 mg three times a day and the dose will be titrated upwards as per change in phosphate levels. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient willing to give written informed consent.
2) Age of 18 years or more.
3) Patients of any gender with current clinical diagnosis of Stage 3 CKD and above as per KDIGO guidelines.
5) Patients with no planned renal transplant during study period
|
|
| ExclusionCriteria |
| Details |
1. Significant gastro-intestinal disorder (including, but not limited to known active peptic ulcer, Crohn’s disease, ulcerative colitis, irritable bowel syndrome, GI motility disorder)
2. Current malignancy
3. Patients on treatment of osteoporosis
4. Patients on treatment of thiazide diuretics
5. Patients receiving Intravenous Iron Supplements.
6. Patients with history of renal calculus
7. Pregnant and lactating women
8. Known hypersensitivity to phosphate binders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in serum phosphate levels. |
Recruitment period for 6 months after CTRI approval.
First follow up at 9 months after CTRI approval.
Second follow up at 12 months after CTRI approval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Hyperphosphataemia represents a significant challenge in the management of chronic kidney disease, exerting a pronounced influence on the pathogenesis of cardiovascular complications and mineral bone disorders. Hyperphosphataemia is defined by a serum level higher than 4.5 mg/dL or 1.78 mmol/L. Hyperphosphatemia occurs in CKD when reduced renal phosphate excretion and other homoeostatic mechanisms fail to eliminate excess phosphate. The inability to control serum phosphate level in chronic kidney disease (CKD) patients is a potentially life altering condition that can lead to cardiovascular calcification, metabolic bone disease (renal osteodystrophy) and the development of secondary hyperparathyroidism (SHPT). This thesis will focus on contributing to understanding of the effect of Ferric citrate and Sevalamer carbonate on hyperphosphatemia in patients of Chronic Kidney disease. Publications will be done using the data and results obtained during the research. |