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

First listed
Jun 9, 2023
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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