Testosterone Replacement for Kidney Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether testosterone replacement therapy (TRT) can aid recovery for men with end-stage kidney disease undergoing a kidney transplant. It examines the safety and effectiveness of adding TRT to the usual surgery recovery plan. Eligible participants are men with low testosterone levels and symptoms like fatigue, scheduled for a kidney transplant within six months. The trial compares recovery and overall health after surgery between those receiving TRT and those who do not. As a Phase 1 and Phase 2 trial, this research aims to understand how TRT works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in transplant recovery.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are already on testosterone or other androgen therapies, you cannot participate in this trial.
Is there any evidence suggesting that testosterone replacement therapy is likely to be safe for humans?
Studies have shown that testosterone replacement therapy (TRT) can be a safe option for people with long-term kidney problems. One study found that TRT safely and effectively restores normal testosterone levels in patients on dialysis and those who have had kidney transplants. These patients often experience improvements in their hormone levels without major safety concerns.
Research also suggests that TRT may lower the risk of kidney issues. Specifically, men receiving testosterone therapy have a reduced risk of sudden kidney problems, indicating that TRT might be well-tolerated in people with kidney diseases.
While these findings are promising, TRT should be used carefully, especially in people with chronic kidney disease. Patients should always consult healthcare providers to discuss potential risks and benefits before starting any new treatment.12345Why do researchers think this study treatment might be promising for kidney failure?
Testosterone Replacement Therapy (TRT) is unique because it targets low testosterone levels that are common in people with kidney failure, which is not typically addressed by standard treatments like dialysis or kidney transplants. Researchers are excited about TRT because it offers a new way to potentially improve muscle mass, bone density, and overall quality of life for those with kidney failure, beyond what current options can achieve. Additionally, by directly supplementing testosterone, TRT could help mitigate some of the systemic effects of kidney failure, offering a more holistic approach to managing the condition.
What evidence suggests that testosterone replacement therapy might be an effective treatment for end-stage renal disease?
Research has shown that testosterone replacement therapy (TRT) may benefit men with kidney problems. In this trial, some participants will receive TRT, which studies have found can improve kidney function in men with low testosterone levels, a condition that often worsens without treatment. For patients on dialysis or who have had kidney transplants, TRT safely restored testosterone levels to normal and improved overall health outcomes. Additionally, men receiving testosterone treatment had a lower risk of sudden kidney problems and kidney failure. These findings suggest that TRT could enhance surgery results for men with severe kidney disease undergoing kidney transplants.23678
Are You a Good Fit for This Trial?
This trial is for men with end-stage renal disease (ESRD) who are hypogonadal, meaning they have low testosterone levels (<300 on two occasions) and symptoms of hypogonadism. They should be expecting a kidney transplant within the next 6 months and can start testosterone replacement therapy at least 3 months before the surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Transplant Testosterone Replacement Therapy
Participants receive testosterone replacement therapy ideally for at least 3 months prior to transplantation
Transplantation and Immediate Post-Transplant Care
Participants undergo kidney transplantation and receive immediate post-operative care
Follow-up
Participants are monitored for safety and effectiveness after transplantation, including assessments at 3, 6, and 12 months post-transplantation
What Are the Treatments Tested in This Trial?
Interventions
- Testosterone Replacement Therapy
Trial Overview
The study tests if adding testosterone replacement therapy to an enhanced recovery after surgery protocol benefits male ESRD patients undergoing kidney transplantation. It compares those on TRT for different durations against a control group not using TRT, looking at safety and how well the new kidney works post-transplant.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Citations
The impact of long-term Testosterone Therapy (TTh) in ...
The results suggest that long-term TTh could improve renal function in hypogonadal men comparing to slight deterioration observed in patients without ...
Testosterone deficiency and chronic kidney disease
The consequences of low testosterone in CKD are profound, with studies suggesting that testosterone replacement therapy (TRT) might improve clinical outcomes, ...
A case series of the safety and efficacy of testosterone ...
We evaluated TRT in HD and renal transplant patients and found it a safe and successful treatment strategy capable of restoring normal T levels and improving ...
Testosterone therapy is associated with reduced risk of ...
Testosterone-treated men had significantly lower risk of acute kidney injury (HR: 0.93 [95% CI 0.87-0.98], p = 0.01) and kidney failure with ...
Long-term Testosterone Therapy Improves Renal Function ...
Conclusion: The data suggest that long-term TTh improves the renal function in hypogonadal men, compared to slight worsening observed in ...
Testosterone therapy is associated with reduced risk of ...
Testosterone-treated men had significantly lower risk of acute kidney injury (HR: 0.93 [95% CI 0.87–0.98], p = 0.01) and kidney failure with ...
A case series of the safety and efficacy of testosterone ...
Recent studies show increased mortality for dialysis and transplant patients with low testosterone (T). These patients are often not treated due ...
Testosterone Replacement Therapy in Advanced Chronic ...
We hypothesize that physiologic TT replacement will be effective in preventing and treating the loss of muscle mass and function in CKD patients.
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