Diabetic nephropathy treatment trial ended early after showing no improvements
A trial of a prospective treatment for diabetic nephropathy (kidney disease) has been ended early after the drug failed to show evidence of progress at any of the doses.
The drug being tested was an anti-transforming growth factor beta-1 (anti-TGF-β1) monoclonal antibody therapy. Previous research had linked the TGF-β1 antibody with development of kidney disease and it was hoped that blocking this antibody could help to hold back development of the condition.
The study, which was carried out by researchers at Eli Lilly & Co. in Indianapolis, tested the therapy on 416 patients with type 1 or type 2 diabetes and at high risk of rapidly developing kidney disease. The majority, 90% of participants, had type 2 diabetes and average age of the participants was 62 years old. The participants were randomly assigned to receive either one of three different doses of the anti-TGF-β1 therapy or placebo. The doses tested were 2, 10 or 50mg per month.
No evidence of success
The primary aim of the study was to observe a reduction in level of serum creatinine (a marker of kidney disease progression). However, the study was ended 4 months early after no dose of the drug showed evidence of outperforming the placebo.
The results were as follows prior to the study being ended:
- Placebo: Serum creatinine increased 2.22 to 2.48 mg/dl
- 2mg/month anti-TGF-β1: Serum creatinine increased 2.15 to 2.49 mg/dl
- 10mg/month anti-TGF-β1: Serum creatinine increased 2.13 to 2.49 mg/dl
- 50mg/moth anti-TGF-β1: Serum creatinine increased 2.15 to 2.50 mg/dl
The anti-TGF-β1 therapy had performed well, holding back the presence of protein in the urine and further kidney damage in rodents with diabetes, so it is disappointing that the treatment failed to achieve similar success in humans.
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