Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000265774p
Ethics application status
Submitted, not yet approved
Date submitted
1/12/2021
Date registered
14/02/2022
Date last updated
14/02/2022
Date data sharing statement initially provided
14/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Renal Outcome with Empagliflozin in non-diabetic Chronic Kidney Disease Patients: A Randomized Control Trial
Scientific title
Effect of Empagliflozin on the slope of eGFR in non-diabetic Chronic Kidney disease patients: A randomized Control Trial
Secondary ID [1] 305954 0
Nil Known
Universal Trial Number (UTN)
U1111-1272-1278
Trial acronym
RECONNECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 324550 0
Condition category
Condition code
Renal and Urogenital 322019 322019 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research will involve the patients taking 10mg orally (tablet) of empagliflozin daily.
The duration will be 90 days. The adherence will be monitored by asking the patients to bring back the empty tablet package material with them.


Intervention code [1] 322345 0
Treatment: Drugs
Comparator / control treatment
Standard Care therapy.
Chronic kidney disease Management:
Kidney Disease Improving Global Outcomes(KDIGO) guidelines for Chronic kidney disease(CKD) management will be followed
1. Anemia Management:
Tablet Iron, Tablet folic acid, subcutaneous erythropoietin injection.
2. Mineral bone disorder:
Calcium acetate tablet, sevelamer tablet, Alpha calcidol tablet.
Health Advice:
Salt restriction, fluid restriction, restriction of potassium rich foods e.g banana and dates, daily exercise.
Control group
Active

Outcomes
Primary outcome [1] 329776 0
Change in the baseline of eGFR. This will be measured according to the EPI-CKD equation. It will be done by a blood test.
Timepoint [1] 329776 0
Baseline Estimated Glomerular filtration rate.
Estimated Glomerular filtration rate 30 days, 60 days, 90 days post-commencement of intervention (primary endpoint)
Secondary outcome [1] 403725 0
Change in the baseline of proteinuria.
It will be assessed by taking a urine sample and checking for spot urine creatinine ratio.
Timepoint [1] 403725 0
Baseline urinary proteinuria,
Commencement of intervention:
Urinary proteinuria after 30 days
Urinary proteinuria after 60 days
Urinary proteinuria after 90 days
Secondary outcome [2] 403726 0
Change in the lipid profile.
Blood test will be done to measure the outcome
Timepoint [2] 403726 0
Baseline Total Cholesterol
Baseline High density lipoprotein cholesterol
Baseline Low density lipoprotein cholesterol
Baseline Triglycerides
Commencement of Intervention:
Total Cholesterol after 30 days
High density lipoprotein cholesterol after 30 days
Low density lipoprotein cholesterol after 30 days
Triglycerides after 30 days
Total Cholesterol after 60 days
High density lipoprotein cholesterol after 60 days
Low density lipoprotein cholesterol after 60 days
Triglycerides after 60 days
Total Cholesterol after 90 days
High density lipoprotein cholesterol after 90 days
Low density lipoprotein cholesterol after 90 days
Triglycerides after 90 days
Secondary outcome [3] 403727 0
Change in blood pressure.
The blood pressure will be measured by a Sphygmomanometer,
Timepoint [3] 403727 0
Baseline systolic blood pressure
Commencement of Intervention:
Systolic blood pressure after 30 days
Systolic blood pressure after 60 days
Systolic blood pressure after 90 days
Baseline diastolic blood pressure
Commencement of Intervention:
Diastolic blood pressure after 30 days
Diastolic blood pressure after 60 days
Diastolic blood pressure after 90 days
Secondary outcome [4] 403728 0
Change in Body Mass Index, BMI
It will be measured by measuring weight in kilograms and height in inches.
Timepoint [4] 403728 0
Baseline body mass index
Commencement of Intervention:
Body mass index after 30 days
Body mass index after 60 days
Body mass index after 90 days
Secondary outcome [5] 403729 0
Frequency of Urinary Tract infection, UTI
It will be assessed by patients history and medical records.
Timepoint [5] 403729 0
Baseline frequency of urinary tract infection
Commencement of Intervention:
Frequency of urinary tract infection after 30 days
Frequency of urinary tract infection after 60 days
Frequency of urinary tract infection after 90 days

Eligibility
Key inclusion criteria
Non-diabetic CKD patients, stage 3&4.
Age greater than or equal to 18 years.
Both male & females
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major surgery during the last 6 months
Pregnant or nursing mothers
Patients on transplantation list
Patients on dialysis
Patients who are allergic to any drug
Patients with malignancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study aims at assessing whether Empagliflozin added with Standard therapy slows down the progression of CKD compared to standard therapy alone in non-diabetic CKD patients. It is estimated that approximately 70 patients per arm will provide a power of 80% to detect a significant effect in the progression of CKD with Empagliflozin and Standard therapy, assuming type I error (alpha) of 5%, reference survival exponential hazard rate of 7.5%, and hazard ratio of 61% .For this type of clinical trial, multivariate analysis of covariance (MANCOVA) main effect model is the most efficient approach with smallest variance estimator. MANCOVA is more meaningful conceptually because pre-score is the baseline covariates, and because there are multiple outcomes. MANCOVA tests the overall null hypothesis that all groups have the same means on the various dependent variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/02/2022
Actual
Date of last participant enrolment
Anticipated
21/03/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 24362 0
Pakistan
State/province [1] 24362 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 310295 0
Self funded/Unfunded
Name [1] 310295 0
Country [1] 310295 0
Primary sponsor type
Individual
Name
Zara Nisar
Address
Khyber medical University, Phase 5, Hayatabad, Peshawar, Khyber Pakhtunkhwa, 25000
Country
Pakistan
Secondary sponsor category [1] 311413 0
None
Name [1] 311413 0
Address [1] 311413 0
Country [1] 311413 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309958 0
Institutional review board, Khyber Medical University
Ethics committee address [1] 309958 0
Khyber medical University, phase 5, Hayatabad, Peshawar, 25000
Ethics committee country [1] 309958 0
Pakistan
Date submitted for ethics approval [1] 309958 0
03/12/2021
Approval date [1] 309958 0
Ethics approval number [1] 309958 0

Summary
Brief summary
Chronic kidney disease is a serious public health problem as it is one of the major causes of hospitalization worldwide. Despite receiving medical treatment, the outcomes remain either fast progression to dialysis or transplantation. The findings of the EMPEROR Reduced trial and DAPA CKD trials support our rationale to further explore the effects of the drug beyond the diabetic patients. we would further like to explore the effects on just CKD patients and how does this drug affect the progression of CKD.
It is hypothesized that by including this drug with the standard of treatment, it will slow down the progression of Chronic kidney disease to next stage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115990 0
Dr Saima Afaq
Address 115990 0
Director ,IPHSS, Khyber Medical University, Phase 5, Hayatabad, Peshawar, 25000
Country 115990 0
Pakistan
Phone 115990 0
+923039424535
Fax 115990 0
Email 115990 0
saima.iph@kmu.edu.pk
Contact person for public queries
Name 115991 0
Dr Zara Nisar
Address 115991 0
Khyber medical University, Khyber Medical University, Phase 5, Hayatabad, Peshawar, 25000
Country 115991 0
Pakistan
Phone 115991 0
+923239519743
Fax 115991 0
Email 115991 0
nisarzara@gmail.com
Contact person for scientific queries
Name 115992 0
Dr Hassan Sajjad
Address 115992 0
Rehman Medical Institute, Phase 5, Hayatabad, Peshawar, 25000
Country 115992 0
Pakistan
Phone 115992 0
+923335031589
Fax 115992 0
Email 115992 0
hsn.pmc@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy of patients


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14309Study protocol    Once published will be available
14310Statistical analysis plan    383233-(Uploaded-18-01-2022-05-40-59)-Study-related document.docx
14311Informed consent form    383233-(Uploaded-01-12-2021-19-10-59)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.