Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - a Pilot Study

Sponsor
Iain Bressendorff
Study ID
NCT05897372
Phase
PHASE2
Status
Terminated

Conditions

  • Diabetic Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this trial is to investigate the feasibility and safety of implementing a protocol-based treatment aggressively targeting albuminuria in subjects with biopsy-proven diabetic nephropathy and severely elevated albuminuria. If this approach is feasible, the results of the trial will inform the design of a large-scale randomized clinical trial to evaluate the effect of this treatment on hard kidney endpoints (initiation of dialysis, kidney transplantation, and death from kidney failure) in subjects with biopsy-proven diabetic nephropathy and severely elevated albuminuria.

Key Dates

Start date
Aug 1, 2023
Status verified
Sep 2024
Primary completion
Sep 23, 2024
Completion
Sep 23, 2024

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care
    Maximally tolerated dose of ACEi or ARB (but not both), SGLT2i, and finerenone. Blood pressure target \<130/80 mm Hg
  • Experimental: Albuminuria-reduction protocol
    Maximally tolerated dose of ACEi or ARB (but not both), SGLT2i, and finerenone. Thereafter addition of semaglutide, pentoxifylline, hydrochlorothiazide, and baricitinib. Blood pressure target \<130/80 mm Hg, but if still UACR \>300 further reduction in blood pressure will be attempted as tolerated.

Primary Outcome Measure

urine albumin/creatinin-ratio (UACR) reduction to less than 50% of baseline [ Time Frame: after 9 months of treatment ]

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