| CTRI Number |
CTRI/2025/10/095598 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to test the safety and usefulness of Ferric Citrate in children with chronic kidney disease and high blood phosphorus |
|
Scientific Title of Study
|
Efficacy and safety of Ferric Citrate for Hyperphosphatemia in Children with Chronic Kidney Disease Stages 3 to 5 An open label randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepthika Sadasivam |
| Designation |
Senior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Renal Children Clinic,
APC 4D 4420
Advanced Pediatric Centre,
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
08508550303 |
| Fax |
|
| Email |
ss.deepthika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lesa Dawman |
| Designation |
Associate Proffesor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
APC 5D- Room No - 5120
Advanced Pediatrics Centre,
PGIMER, CHandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9971957223 |
| Fax |
|
| Email |
lesadawman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lesa Dawman |
| Designation |
Associate Proffesor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
APC 5D - Room no 5120
Advanced Pediatrics Centre,
PGIMER, CHandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9971957223 |
| Fax |
|
| Email |
lesadawman@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER, Chandigarh |
| Address |
Advanced Pediatrics Centre,
PGIMER Chandigarh- 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Deepthika Sadasivam |
PGIMER |
Renal Children Clinic - Wednesday,
Advanced Pediatric Centre 4D 4419-20
PGIMER,
Chandigarh
Chandigarh
CHANDIGARH |
08508550303
ss.deepthika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh, India |
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), (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (3) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ferric citrate |
Weight based dose of Ferric citrate
• 3 g/day for children 31 kg
• 5 g/day for children 31–50 kg
• 6 g/day for children 51 kg
Drug: Ferric citrate-Phoscut FER – Ferric citrate 1 g with elemental iron equivalent to 210 mg |
| Comparator Agent |
Sevalamer |
starting at 400mg three times daily and increasing upto 800mg three times daily depending on the serum phosphate levels and given for six months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 6 to 14 years
2. Estimated glomerular filtration rate of less tha 60ml per min per 1.73m2 by Modified Schwartz formula
3. Serum phosphate levels greater than 5mg per dL or above the age-adjusted reference range on two occasions
4. Haemoglobin less than 11.5 g per dl for 5-11 years and less than 12 g per dl for 12-14 years.
5. Serum Ferritin less tha 500ng per ml and Transferrin saturation less than 50 percentage
6. Doses of iron, ESA, vitamin D3, calcium carbonate, and calcitriol must be stable for at least 2 weeks before enrolment.
7. Children who can take oral tablets
8. Parents or guardians willing to come for follow-up and comply with the treatment regime
|
|
| ExclusionCriteria |
| Details |
1. Patients on dialysis
2. Prior solid organ transplantation
3. History of intestinal malabsorption, gastrointestinal bleeding, severe hepatic dysfunction
4. Active infection or malignancy
5. Retroviral disease
6. Haemochromatosis
7. Known allergy to phosphate binders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To assess the efficacy of oral ferric citrate in reducing serum phosphate levels at 6 months of treatment in children aged 4–14 years with hyperphosphatemia in CKD stages 3-5. |
• To assess the efficacy of oral ferric citrate in reducing serum phosphate levels at 6 months of treatment in children aged 4–14 years with hyperphosphatemia in CKD stages 3-5. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the effect of ferric citrate on fibroblast growth factor 23 levels, which is a key regulator of phosphate metabolism and cardiovascular risk. |
6 months |
| 2. To assess the influence of ferric citrate on cardiovascular outcomes by determining the changes in the left ventricular mass index (LVMI) as a measure of cardiac remodelling |
6 months |
| 3. To assess the changes in iron indices (hemoglobin, ferritin, and transferrin saturation) from baseline to the end of treatment |
6 months |
| 4. To evaluate the changes in bone metabolism markers, including calcium, parathyroid hormone, and alkaline phosphatase, from baseline to the end of treatment |
6 months |
| 5. To assess the overall safety and tolerability profile of ferric citrate in pediatric patients with CKD. |
4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
28/10/2025 |
| 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="6"
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
|
Hyperphosphatemia is a major complication in children with chronic kidney disease (CKD), contributing to mineral bone disorder, growth impairment, anemia, and cardiovascular disease. Current phosphate binders are limited by side effects and poor tolerability in children. Ferric citrate is a novel oral phosphate binder that also provides bioavailable iron, thereby addressing both hyperphosphatemia and iron deficiency anemia. While extensively studied in adults, data in pediatric CKD patients are scarce. This single-centre, open-label randomized controlled trial at PGIMER, Chandigarh, will evaluate the efficacy and safety of ferric citrate compared to sevelamer carbonate in children aged 6–14 years with CKD stages 3–5 and hyperphosphatemia. A total of 90 children will be randomized (1:1) to receive either weight-based ferric citrate or standard-dose sevelamer for 24 weeks. The primary endpoint is the reduction in serum phosphate at 6 months. Secondary endpoints include changes in fibroblast growth factor 23 (FGF23), echocardiographic and carotid intima-media thickness measures of cardiovascular status, iron indices (hemoglobin, ferritin, transferrin saturation), and bone metabolism markers. Safety will be assessed through monitoring adverse events and biochemical markers of iron overload or hypophosphatemia. The study aims to generate pediatric-specific evidence on ferric citrate as a dual-action therapy, potentially improving phosphate control, iron status, and cardiovascular outcomes in children with CKD. |