Kidney Week

Abstract: TH-PO450

Levothyroxine in Proteinuric CKD Patients Decreases Proteinuria and Improves Kidney Function: A Randomized, Double-Blind, Clinical Trial

Session Information

• CKD: Clinical, Outcomes, Trials - I
  November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Navarro Blackaller, Guillermo, Hospital Civil de Guadalajara, Guadalajara, Mexico

Guillermo Navarro Blackaller,

• Garcia-Garcia, Guillermo, Hospital Civil de Guadalajara, Guadalajara, Mexico

Guillermo Garcia-Garcia,

• Chavez, Jonathan, Hospital Civil de Guadalajara, Guadalajara, Mexico

Jonathan Chavez,

• Carreon bautista, Elsa edith, Hospital Civil de Guadalajara, Guadalajara, Mexico

Elsa edith Carreon bautista,

• Maggiani, Pablo, Hospital Civil de Guadalajara, Guadalajara, Mexico

Pablo Maggiani,

• Michel gonzález, Jorge Isaac, Hospital Civil de Guadalajara, Guadalajara, Mexico

Jorge Isaac Michel gonzález,

• Romo rosales, Francisco D., Hospital Civil de Guadalajara, Guadalajara, Mexico

Francisco D. Romo rosales,

Background

Thyroid hormomes can affect kidney function. Elevated levels of TSH in CKD patients is associated to proteinuria, decrease in GFR, and progression to ESRD. We hypothesized that the use of levothyroxine (LTX) in proteinuric CKD patients with TSH levels between 2.5- 9.9 μIU/mL and normal FT4, decreases proteinuria and improves kidney function. Clinical trial registration number: NCT03898622

Methods

A double-blind, phase 2 randomized clinical trial, in proteinuric CKD patients, stage 3-5, not on dialysis, with TSH levels between 2.5-9.9 μIU/mL, and FreeT4 in a range of 0.7-1.8 ng/dL. All patients were already on ACE inhibitors or ARBs. Patients were randomized 1:1 to receive LTX (25-50mcg/day) or placebo for 12 weeks. The main outcomes were change in proteinuria, sCr, eGFR, TSH, and tolerability and safety of LTX.

Results

163 patients were assessed for eligibility; 119 were excluded; 32 patients were randomized. Demographic and clinical characteristics between groups were similar. At 12 weeks, mean change in proteinuria (LTX vs placebo) was –1.1 (-4.1 to +0.9) g/day vs +0.20 (-0.4 to +2.1) g/day (p= 0.001); sCr –0.20 (-0.7 to +0.5) mg/dL vs +0.05 (-0.5 to +1.49) mg/dL (p=0.32); eGFR +4.04 ((+9.8 to -2.0) ml/min/1.73m² vs -1.96 ( (-5.0 to +3.0) ml/min/1.73m² (p=0.049); and TSH -3.2 (-6.8 to +1.6) μIU/dL vs -0.4 (-3.09 a +1.87) μIU/dL (p=0.003), respectively (Fig 1). Adverse events were similar betwwen groups (7.14% vs 11.11%, p=1.0). No patient abandoned treatment because of adverse events.

Conclusion

LTX in proteinuric CKD patients decreased proteinuria and improved kidney function. Further studies are needed to determine the long-term impact of exogenous thyroid hormone treatment on proteinuria and CKD progression.

Mean change in proteinuria, sCr, eGFR, and TSH after 12-week treatment with LTX.