NCT05849220

Brief Summary

The role of Dapagliflozin in the improvement in CKD in both diabetic and non-diabetic patients has been evaluated in the past. SGLT2i have also been found to be beneficial in NAFLD patients in improving the liver function parameters. It is also known that cirrhotic patients are at a higher risk of developing CKD at 1 year when compared to non cirrhotics. With this study we aim to study the role Dapagliflozin in cirrhotic patients in reducing the development of CKD, its impact on cirrhotic cardiomyopathy and its role in improvement of metabolic profile and liver related outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

May 8, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 27, 2023

Last Update Submit

May 5, 2023

Conditions

NAFLD Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Number of participants developing Chronic Kidney Disease at 1 yr defined as per KDIGO guidelines.

    1 year

Secondary Outcomes (12)

  • Number of participants developing Chronic Kidney Disease.

    3 months

  • Number of participants developing Chronic Kidney Disease.

    6 months

  • Improvement in eGlomerular filtration rate (eGFR) at 3 months.

    3 months

  • Change in eGlomerular filtration rate (eGFR) at 6 months.

    6 months

  • Change in eGlomerular filtration rate (eGFR) at 12 months.

    12 months

  • +7 more secondary outcomes

Study Arms (2)

Dapagliflozin+Standard of Care

EXPERIMENTAL

Dapagliflozin

Drug: DapagliflozinOther: Standard of Care

Standard of Care

ACTIVE COMPARATOR

Standard of Care

Other: Standard of Care

Interventions

DapagliflozinDRUG

Dapagliflozin

Dapagliflozin+Standard of Care
Standard of CareOTHER

Standard of Care

Dapagliflozin+Standard of CareStandard of Care

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years \<70years
  • Patient with NAFLD associated cirrhosis and moderate ascites
  • Stable eGFR-(\>60 ml/min/1.73m2) calculated using MDRD-6 equation: eGFR (ml/min/1.73 m2) = 198 × \[serum creatinine (mg/dL)\]-0. 858 × \[age\]-0. 167 × \[0.822 if patient is female\] × \[serum urea nitrogen concentration (mg/dL)\]-0.
  • Valid Informed written consent

You may not qualify if:

  • Hospitalized patients
  • CTP-C patients
  • Intrinsic/structural kidney disease, obstructive uropathy, ADPKD, Anatomic urologic defects that predispose to urinary tract infection
  • History of organ transplantation
  • Refractory Ascites
  • Type 1 DM
  • History of hypoglycemic symptoms in the last 2 months
  • Recurrent UTI
  • Patient with HCC or portal vein thrombosis
  • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
  • History of fracture in the preceding year
  • Severe Hyponatremia (Na \<125 MEq/L)
  • Pregnancy or Lactating mother
  • Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
  • MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

dapagliflozinStandard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Dr Ayush Jain, MD

CONTACT

01146300000jainayush2206@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2023

First Posted

May 8, 2023

Study Start

May 15, 2023

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

May 8, 2023

Record last verified: 2023-03

Locations

IN(1)