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CTRI Number  CTRI/2024/06/068710 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 08/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the improvement in exercise capacity, renal function, and cardiac parameters of participants with chronic kidney disease (CKD), heart failure, and iron deficiency after administering an interventional agent like intravenous iron. 
Scientific Title of Study   To evaluate the impact of intravenous iron therapy in chronic kidney disease patients with heart failure A randomised controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shrinath Mashale 
Designation  Senior Resident 
Affiliation  Post graduate institute of medical education and research 
Address  Dept of Nephrology, Post graduate institute of medical education and research ,Sector12,Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8788974401  
Fax    
Email  shrinathmashale10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Manish Rathi 
Designation  Professor 
Affiliation  Post graduate institute of medical education and research 
Address  Dept of Nephrology, Post graduate institute of medical education and research ,Sector12,Chandigarh Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9216721287  
Fax    
Email  drmanishrathi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shrinath Mashale 
Designation  Senior Resident 
Affiliation  Post graduate institute of medical education and research 
Address  Dept of Nephrology, Post graduate institute of medical education and research,Sector12,Chandigarh Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8788974401  
Fax    
Email  shrinathmashale10@gmail.com  
 
Source of Monetary or Material Support  
Post graduate institute of medical education and research Chandigarh PIN code -160012 India 
 
Primary Sponsor  
Name  Shrinath Mashale 
Address  Senior Resident, Dept of Nephrology, Post graduate institute of medical education and research, Chandigarh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shrinath Mashale  Post graduate institute of medical education and research  Dept of Nephrology, Post graduate institute of medical educaion and research, Chandigarh 160012
Chandigarh
CHANDIGARH 		 8788974401

shrinathmashale10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post graduate institute of medical education and research Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N18||Chronic kidney disease (CKD),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous iron isomaltoside  Patients in the experimental arm will receive IV Iron isomaltoside 1 gm after test dose over 20 minutes. After administration patient will be monitored for 30 minutes to look for any adverse reaction until clinically stable following infusion. 
Comparator Agent  Oral iron ferric pyrophosphate  Control group will receive oral iron (ferric pyrophosphate 30 mg) daily for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age more than 18 years
left ventricular ejection fraction less than 50%
NYHA class 2-4
CKD with estimated glomerular filtration rate less than 60 ml/min/1.73m2
Iron deficiency serum iron less than 800ug/ml and transferrin saturation less than 30%
No previous exposure to intravenous iron therapy within last 3 months 
 
ExclusionCriteria 
Details  Haematological criteria serum ferritin more than 800ug/ml Transferrin saturation more than 30 %
CKD patients on maintenance hemodialysis
Already received IV iron
contraindications to iron therapy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Exercise capacity measured by the six-minute walk test (6MWT)
2)New York Heart Association (NYHA) functional class
3)eGFR
4)MACE 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
•Hemoglobin concentration in CKD patients with anemia.
•Improvement in iron indices (e.g., serum ferritin, transferrin saturation)
•Ejection fraction
•Cardiac markers(pro BNP ,TropT)
Safety Outcomes:
•Adverse events related to intravenous iron administration.
•Infections or complications associated with CKD management
 		 12 weeks 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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 2/ Phase 3 
Date of First Enrollment (India)   20/06/2024 
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)   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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shrinathmashale10@gmail.com].

  6. For how long will this data be available start date provided 19-06-2024 and end date provided 19-06-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This thesis explores the multifaceted role of iron in the complex interplay between chronic kidney disease (CKD) and chronic heart failure (CHF) through a randomized controlled trial (RCT). The study examines the consequences of iron deficiency in these conditions and investigates the potential of iron correction as a therapeutic strategy.

 Specifically, it compares the effectiveness of intravenous (IV) iron isomaltoside 1 gm in one arm versus oral iron in the other arm.

 By highlighting the critical role of iron in managing iron deficiency in patients with CKD and CHF, this research aims to enhance our understanding of the Cardio Renal Iron Deficiency (CRID) syndrome and pave the way for improved treatment modalities in this challenging clinical scenario.

 It also compares exercise capacity and eGFR, EF post 3 months of drug administration.

 
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