NCT06572215

Brief Summary

This is a feasibility study to assess new, more practical ways of measuring renal reserve.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress60%
Dec 2023Dec 2027

Study Start

First participant enrolled

December 14, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

August 23, 2024

Last Update Submit

March 26, 2026

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in eGFR from baseline to 2hours after oral protein load

    2 hours

Study Arms (2)

Healthy Participants

Drug: Dapagliflozin

Patients with hyperfiltration

Drug: Dapagliflozin

Interventions

DapagliflozinDRUG

On Day 3 to 16, participants will take 10mg dapaglifozin (SGLT-2 inhibitor) orally once daily.

Healthy ParticipantsPatients with hyperfiltration

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

: 44 Participants

You may qualify if:

  • Patients with sickle cell nephropathy, diagnosed clinically or histologically. Sickle Cell patients will be confirmed Hb SS and eGFR (CKD-EPI) ≥ 135 ml/min/1.73m2 OR
  • Previous living kidney donation
  • Age ≥ 4No contraindication or known allergy to any trial medications.
  • Willing and able to provide written informed consent

You may not qualify if:

  • Aged \< 40
  • Unable or unwilling to provide informed consent
  • Breastfeeding or pregnant women
  • Patients involved in other interventional research studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine samples

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Kate Bramham, Doctor

CONTACT

0203 299 9000kch-tr.research@nhs.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 27, 2024

Study Start

December 14, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)