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CTRI Number  CTRI/2019/05/019383 [Registered on: 27/05/2019] Trial Registered Prospectively
Last Modified On: 27/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   What happens to phosphorus levels during hemodialysis? 
Scientific Title of Study   Phosphate kinetics in Indian hemodialysis patients - an observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
None  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namrata Rao S 
Designation  Assistant Professor 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow 
Address  Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  09454360872  
Fax    
Email  snamratarao@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Namrata Rao S 
Designation  Assistant Professor 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow 
Address  Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  09454360872  
Fax    
Email  snamratarao@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Namrata Rao S 
Designation  Assistant Professor 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow 
Address  Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  09454360872  
Fax    
Email  snamratarao@yahoo.co.in  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Dr Namrata Rao S 
Address  Department of Nephrology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Lucknow - 226010 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Namrata Rao  Dr. Ram Manohar Lohia Institute of Medical Sciences  Hemodialysis unit, Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH 
09454360872

snamratarao@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethical Committee, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient of endstage renal disease on maintenance hemodialysis for > 3 months
No hospitalizations in the last 3 months
Written, informed consent
 
 
ExclusionCriteria 
Details  Need for hospitalization in the last 3 months
Inability to record diet and drug history
Hemodialysis sessions requiring blood transfusion
Missed session of hemodialysis in the preceding week
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To prospectively evaluate phosphate removal by hemodialysis in patients with endstage renal disease in a tertiary care hospital in northern India  0,1,2,3,4,5 hours after onset of dialysis 
 
Secondary Outcome  
Outcome  TimePoints 
None  NA 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   28/05/2019 
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   1. Reddy YNV, Sundaram V, Abraham G, et al. Optimal management of hyperphosphatemiain end-stage renal disease: an Indian perspective. Int J Nephrol Renovasc Dis. 2014; 7: 391-399. 2. Daugirdas JT. Removal of phosphorus by hemodialysis. Sem Dial. 2015; 28: 620-623. 3. Agar BU, Akonour A, Lo YC, et al. Kinetic model of phosphorus mobilization during and after short and conventional hemodialysis. Clin J Am Soc Nephrol. 2011; 6: 2854-2860. 4. Elias RM, Alvares VRC, Moyses RMA. Phosphate removal during conventional hemodialysis: a decades-old misconception. Kidney Blood Press Res. 2018; 43: 110-114.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Hyperphosphatemia in endstage renal disease patients has been associated with greater risk of mortality, especially due to cardiovascular causes (1). Most commonly, nephrologists employ an approach of dietary phosphorus restriction, use of phosphate binders and hemodialysis, to facilitate maintenance of serum phosphate levels in dialysis patients. A majority of Indian dialysis patients receive two/week hemodialysis sessions, as against three/week in the Western world. Indian diet is vastly different from typical Western diet and various regional differences exist too. Dietary modifications to increase protein and minimize phosphorus intake, are only variably successful, as cost and logistics play greater role in deciding the patient’s diet, rather than the clinician’s advice (1). Therefore, the onus of phosphate removal falls upon a combination of phosphate binders and the hemodialysis sessions.

Brief review: Regarding dialytic phosphorus removal, available literature is unclear whether short, frequent hemodialysis sessions are more beneficial than prolonged sessions in reducing serum phosphorus levels (2,3). To our knowledge, only a single study has evaluated dialytic phosphorus removal over a period of time (4). This study found out that while the first hour of hemodialysis normalizes serum phosphorus levels, significant amount of phosphorus continues to be removed in the subsequent hours as well. The present study will observe dialysis phosphorus removal at hourly intervals and help in deciding which approach will tackle hyperphosphatemia  effectively – increasing dialysis duration or frequency. Moreover, no other study has undertaken the evaluation of dietary phosphorus intake and dialytic phosphorus removal in an Indian population before.  

 
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