Supplementation of Thyroid Hormone for TSH Control in Patients With Chronic Kidney Disease Without TRR.

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Study design: Phase II study, randomized, double-blind, unicentric, two-arm, placebo-controlled clinical trial. Methods and participants: Patients with Chronic Kidney Disease G2-G5 with proteinuria without renal replacement therapy, who come to the clinic of renal health clinic of the Fray Antonio Alcalde civil hospital. As criteria for non-inclusion, need for dialysis, primary hypothyroidism or pre-existing thyroid disease, ischemic heart disease in a period less than 6 months, arrhythmia, pregnancy, use of drugs that interact with synthesis of thyroid hormones, do not accept informed consent, thyroid stimulating hormone (TSH) <2.5 uiml / L or TSH> 10 uiml / L.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Civil de Guadalajara
• Treatments: Hormones

Criteria

Inclusion Criteria:

• • Patients older than 18 years

• Patients with chronic kidney disease G2-G5 without renal replacement therapy) who attend a renal health clinic.

• Presence of proteinuria in a test strip, 24 hours urine collection (greater than 150mg / dl in 24hrs urine)

• TSH <9.9uiml / L and TSH> 2.4 0uiml / L

• Take an IECA or ARA-2

• Patients with weight> 50 kg and <80kg

• Accept informed consent

Exclusion Criteria:

• Chronic dialysis (peritoneal dialysis or hemodialysis)

• Primary hypothyroidism or preexisting thyroid disease

• Use of levothyroxine.

• TSH> 10uiml / L and TSH <2.5 0uiml / L

• Positive thyroid antibodies

• Ischemic heart disease in less than 6 months

• Cardiac arrhythmia

• Use Medications (Levothyroxine synthesis, see Table 2)

• Anxiety disorder

• Pregnancy

• Do not accept consent

• Patients weighing <50 kg and> 80kg