A Crossover Pilot Study of the Effect of Amiloride on Proteinuria
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02522650|
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : February 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Proteinuria||Drug: Amiloride Drug: Triamterene||Phase 4|
Patients with proteinuric kidney disease will be enrolled and receive either amiloride or triamterene first, a similar diuretic acting on epithelial sodium channel (ENaC) as amiloride, but not inhibiting urokinase plasminogen activator receptor (uPAR), will be used as a control. Then patients will cross over to receive another medication. We postulate that amiloride could be beneficial in the patients with proteinuric kidney diseases and could be used as an adjunct therapy to reduce proteinuria and to delay renal disease progression in this patient population.
Specific Aim 1: To examine the effects of amiloride on 24 hour urine protein excretion in patients with proteinuric kidney diseases.
Specific Aim 2: To study if the effect of amiloride on proteinuria reduction is mediated by suppressing soluble urokinase plasminogen activator receptor (suPAR) expression.
The study includes 3 phases. 30 patients will be recruited to this study. All patients need to be on an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) daily at least two month prior to the study.
Phase 1: Patients will be randomized to receive either amiloride 5mg twice daily or triamterene 50mg twice daily for 8 weeks. Serum potassium will be monitored one week before and one week after starting phase 1. If serum potassium remains equal to or less than 5.0mmol/L, amiloride or triamterene will be continued at same dose until the end of phase 1. If serum potassium is equal to or above 5.5 mmol/L, the patient will exit the study, and an adverse event will be reported. If serum potassium is between 5.1-5.4 mmol/L, it will be monitored again in one week. If serum potassium is above 5.5 mmol/L, the patient will exit the study, and an adverse event will be reported. If serum potassium remains in the same range, the patient will continue amiloride or triamterene at the same dose to complete phase 1.
Phase 2: the patients will discontinue amiloride or triamterene for a washout for 4 weeks, but continue with the ACE inhibitor or ARB.
Phase 3: the patients will cross over to triamterene or amiloride for 8 weeks. Use the protocol as described in phase 1.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Crossover Pilot Study of the Effect of Amiloride on Proteinuria in Patients With Proteinuric Kidney Disease|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: Amiloride Phase
Subject receives 5mg of Amiloride twice daily for 8 weeks.
5mg twice a day for 8 weeks
Active Comparator: Triamterene Phase
Subject receives 50mg of Triamterene twice daily for 8 weeks.
50mg twice a day for 8 weeks
No Intervention: Washout Phase
Subject does not take any study medication for 4 weeks
- 24 hr urine protein excretion [ Time Frame: 20 weeks ]Identify changes in 24 hr urine protein excretion throughout the 3 phases of the study.
- urine plasmin activity [ Time Frame: 20 weeks ]examine urine plasmin activity during the 3 phases of the study. Serum and urine plasmin will be measured by gelatin-PAGE zymography.
- urine plasminogen activity [ Time Frame: 20 weeks ]examine urine plasminogen activity during the 3 phases of the study. urine plasminogen will be measured by gelatin-PAGE zymography.
- urine suPAR concentration [ Time Frame: 20 weeks ]examine urine suPAR concentration during the 3 phases of the study. suPAR concentration will be measured by ELISA kit.
- serum suPAR concentration [ Time Frame: 20 weeks ]examine serum suPAR concentration during the 3 phases of the study. suPAR concentration will be measured by ELISA kit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522650
|Contact: Margie Dimatulacfirstname.lastname@example.org|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007|
|Contact: Margie Dimatulac 202-444-1210 email@example.com|
|Contact: MD 202-444-1089|
|Principal Investigator: Wen Shen, MD, PhD|
|Principal Investigator:||Wen Shen, MD, PhD||Georgetown University Hospital|