| CTRI Number |
CTRI/2024/05/066877 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This research aims to understand better treatment approaches for managing anemia in patients with CKD, with the ultimate goal of significantly enhancing patient care and overall treatment outcomes. |
|
Scientific Title of Study
|
Anemia Management in Chronic Kidney Disease: A Comparative Evaluation of Hypoxia-Inducible Factor-Prolyl Hydroxylase Domain (HIF-PHD) Inhibitor(s) and Erythropoiesis Stimulating Agents(ESAs) |
| 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 Pramil Tiwari |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Pharmaceutical Education and Research (NIPER) Mohali |
| Address |
Department of Pharmacy Practice Sector 67 SAS Nagar 160062 Punjab India Room No 205 Rupnagar
Rupnagar
PUNJAB
160062
India |
| Phone |
9478401174 |
| Fax |
|
| Email |
ptiwari@niper.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Dcruz |
| Designation |
Professor and Head |
| Affiliation |
Goverment Medical College and Hospital (GMCH) Chandigarh) |
| Address |
Department of General Medicine Sector 32 Chandigarh India Room No 410 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121556 |
| Fax |
|
| Email |
sanjaydcruz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Tahlan |
| Designation |
Professor |
| Affiliation |
Goverment Medical College and Hospital (GMCH) Chandigarh) |
| Address |
Department of Pathology Sector 32 Chandigarh India Room No 327 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646862601 |
| Fax |
|
| Email |
anitatahlan@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Pharmaceutical Education and Research, Mohali, Punjab India |
|
|
Primary Sponsor
|
| Name |
National Institute of Pharmaceutical Education and Research, Mohali |
| Address |
Sector 67 SAS Nagar (Mohali) 160062 Punjab (India) |
| Type of Sponsor |
Research institution |
|
|
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 Sanjay DCruz |
Goverment Medical College and Hospital (GMCH) Chandigarh) |
Department of General Medicine (Special Nephrology Clinic) Room No 410 sector 32 Chandigarh 160030
Chandigarh
CHANDIGARH |
9646121556
sanjaydcruz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (GMCH, Chandigarh) Sector 32-B, Chandigarh-160030 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erythropoiesis-stimulating agents
Such as Epoetin alfa and Darbepoetin alfa |
Subcutaneous or intravenous dose administered for ≥12 weeks.
ESAs are medications that stimulate the production of red blood cells in the bone marrow, commonly used to treat anemia associated with chronic kidney disease.
|
| Intervention |
Hypoxia-Inducible Factor-Prolyl Hydroxylase Domain (HIF-PHD) inhibitor(s)
Such as Desidustat and Roxadustat |
Oral dose (100-150 mg) administered once daily for ≥12 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Oral hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) that has been approved for treating anemia in kidney disease patients
1. Effectively raising or preserving hemoglobin levels
2. Induces a rise in endogenous EPO production within the desired physiological range
3. Exerts control over iron metabolism, specifically by reducing the levels of hepcidin
4. Enhances the absorption of iron and remains unaffected by inflammation
5. Not associated with any risk of hypertension
6. Help to reduce cholesterol levels
7. Prevents the occurrence of excessively high levels of EPO
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
A. All patients who are diagnosed with CKD with renal anemia & undergoing dialysis
B. Patient should have been on dialysis for at least 3 months.
C. Patients between 18-75 years will receive HIF-PHD inhibitors or ESAs
|
|
| ExclusionCriteria |
| Details |
A. Inability to give informed consent
B. Patients unable to complete the interview
C. Psychiatric illness
D. History of malignancy
E. Any active or recent history of blood loss
F. Taking part in other drug study
G. Pregnant and breastfeeding women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change(s) in hemoglobin from baseline to 3
rd, 6th and 12th
months.
2. Changes in the iron utilization parameters, including
serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin,
RET-He and relevant biochemistry laboratory results from
baseline. |
3rd, 6th and 12th
months(1 Year). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes of the study will focus on the treatment-emergent adverse effects (TEATs) & serious adverse events, cardiovascular events, & hospitalization. The study will report adverse events during the follow-up period, with a focus on drug discontinuation due to adverse events.
To determine the differences in the treatment cost among CKD patients with anemia undergoing dialysis
To assess the HRQoL of dialysis patients.
To analyze the mortality.
CKD-AQ (chronic kidney disease-Anemia Questionnaire) will be used for the assessment of Anemia in CKD. |
3rd 6th & 12 months(1 year) |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
14/05/2024 |
| 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="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
|
Chronic Kidney Disease (CKD) is a prevalent condition worldwide, with a significant number of patients progressing to end-stage renal disease (ESRD) and requiring dialysis. These patients often have anemia, which is a common complication of CKD. This is associated with poorer quality of life, increased healthcare costs, and a higher risk of mortality. Traditionally, erythropoiesis-stimulating agents (ESAs) have been the standard of care for managing anemia in CKD patients undergoing dialysis. However, recent research has explored the potential of Hypoxia-Inducible Factor-Prolyl Hydroxylase Domain (HIF-PHD) inhibitors as an alternative option. The potential benefits of HIF-PHD inhibitors include- they are orally-administered, effectively raise or preserve hemoglobin levels, and induce an increase in endogenous EPO production within the desired physiological range. They exert control over iron metabolism, particularly by reducing hepcidin levels, enhance iron absorption, and remain unaffected by inflammation. Additionally, they may contribute to reducing cholesterol levels and have demonstrated potential cardioprotective effects with decreased inflammation. This study aims to evaluate the effectiveness and safety of HIF-PHD inhibitor(s) against the standard treatment in CKD patients with anemia. Further, the estimation of safety, cost of treatment and quality of life of anemic chronic kidney disease patients undergoing dialysis are also proposed. |