| CTRI Number |
CTRI/2024/02/062658 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effect of desidustat in comparison to erythropoietin in patients of anemia with chronic kidney disease. |
|
Scientific Title of Study
|
Randomized controlled trial to compare the safety and efficacy of desidustat with erythropoietin in adult patient suffering from anemia 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 |
Dr Sachin Sharma |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College Tanda HP |
| Address |
Department of Pharmacology, 3rd floor, Para clinic Block, Dr RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH
176002
India |
| Phone |
9459146300 |
| Fax |
|
| Email |
s1984kaka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atal Sood |
| Designation |
Professor and Head |
| Affiliation |
Dr Rajendra Prasad Government Medical College Tanda HP |
| Address |
Department of Pharmacology, 3rd Floor, Para clinic Block, DR RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH
176002
India |
| Phone |
9418063191 |
| Fax |
|
| Email |
atalsood7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinav Rana |
| Designation |
Assistant Professor and Head |
| Affiliation |
Dr Rajendra Prasad Government Medical College Tanda HP |
| Address |
Department of Nephrology, Superspeciality Building, 1st floor, Dr RPGMC Kangra at Tanda.
Kangra
HIMACHAL PRADESH
176002
India |
| Phone |
7018812729 |
| Fax |
|
| Email |
abhinavrana2729@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Government Medical College Tanda HP |
|
|
Primary Sponsor
|
| Name |
Dr Sachin Sharma |
| Address |
Junior Resident Department Of Pharmacology Dr RPGMC Tanda Kangra HP |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MultiDisciplinary Research Unit |
Multi-Disciplinary Research Unit Govt of India center at Dr Rajendra Prasad Government Medical College Tanda HP |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sachin Sharma |
Dr Rajendra Prasad Government Medical College Tanda HP |
Department of Nephrology, Superspeciality Building, first Floor, Dr RPGMC Tanda.
Kangra
HIMACHAL PRADESH |
9459146300
s1984kaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Dr Rajendra Prasad Government Medical College Kangra at Tanda |
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 |
| Intervention |
Desidustat |
Tab desidustat 50 mg orally three times a week with maximum dose increased Upto 150 mg three times a week depend on hemoglobin level. |
| Comparator Agent |
Erythropoietin |
Erythropoietin injection subcutaneous 50 IU per kg to 450 IU per kg twice or thrice a week depend on hemoglobin level |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to give written informed consent. 2.Age more than 18 years. 3.Male or female patient with current clinical diagnosis of anemia due to CKD having baseline hemoglobin concentrations ≤10.0 g/dl before the enrolment. 4)If patients are on dialysis they should be on adequate dialysis (as prescribed) on either 2 or 3 times per week hemodialysis for at least 12 weeks prior to screening. 5)Patients with no planned renal transplant during study period. 6)Adequate serum ferritin and/or TSAT as per KDIGO guidelines. 7)No iron, folate or vitamin B12 deficiency.
|
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years.
2.Patients who received red blood cell transfusion within 8 weeks prior to enrollment.
3.Hematological malignancy or primary hematological disease.
4.Malignancy of any organ.
5.Presence or a history of bleeding disorder.
6.Serological status reflecting active hepatitis B or C or Human immunodeficiency virus (HIV) infection.
7.History of renal transplant.
8.Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestinal absorption such as mal absorption syndrome, resection of small bowel or poorly controlled inflammatory bowel disease affecting small intestine.
9.History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
10.Known hypersensitivity to investigational products or with known contraindications to any of the study drug.
11.Women who are trying to conceive, pregnant and breast-feeding women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in hemoglobin. |
Baseline to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in hematological and biochemical parameters as mentioned in protocol annexure III) before and after receiving drug like Serum Hepcidin level, Vitamin D, Phosphate, Parathormone, Lipid Profile
|
Baseline to 3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "109"
Final Enrollment numbers achieved (India)="109" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/02/2024 |
| Date of Study Completion (India) |
14/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Our plan is to conduct a randomized trial to compare the safety and efficacy of desidustat with erythropoietin. The result of this study will generate more evidence for the clinician to use this drug in pharmacotherapy of anemia due to CKD. The study result will add to current limited evidence of newly approved drug desidustat for its efficacy and safety for its use in anemia due to CKD. If acceptable risk-benefit ratio is proven, this drug can also be utilized in other causes of anemia where there is role of hepcidin in the pathophysiology of the anemia. |