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Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant (PTN_LISINO)
This study is currently recruiting participants.
Verified April 2013 by Duke University
Sponsor:
Uptal Patel
Collaborator:
Information provided by (Responsible Party):
Uptal Patel, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01491919
First received: November 29, 2011
Last updated: April 22, 2013
Last verified: April 2013
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Purpose
The drug lisinopril is approved by the U.S. Food and Drug Administration for the treatment of high blood pressure, heart failure, and acute heart attacks in adult patients. In children over 6 years of age, lisinopril is approved for the treatment of high blood pressure. Lisinopril is in a group of medications called angiotensin-converting enzyme inhibitors (ACE). ACE inhibitors such as lisinopril work by decreasing certain chemicals that tighten the blood vessels so blood flows more smoothly and the heart can pump blood more efficiently.
There is some information available about how children with high blood pressure absorb, distribute, metabolize, and eliminate lisinopril (this information about medication processing by the body is called pharmacokinetic data). However, there is no information about how children with high blood pressure who have received a kidney transplant process lisinopril. In addition to decreasing blood pressure, investigators believe that lisinopril may help kidney transplants work longer by reducing the activity of chemicals made by cells in kidney transplants that can lead to inflammation and injury. Such benefits have not been found with another group of blood pressure medications called calcium channel blockers, which are the most commonly used medication group to control high blood pressure in children after a kidney transplant. A clinical trial will be conducted in the future to compare which medication group helps kidney transplants in children last longer. To guide the selection of the best dose to test in future studies, investigators in this study will try to determine the safety profile, dose tolerability, and pharmacokinetics of lisinopril in children and adolescents (2-17 years of age) who have received a kidney transplant and have high blood pressure.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Lisinopril |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Pharmacokinetics of Lisinopril in Pediatric Kidney Transplant Recipients |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Pharmacokinetics (PK) [ Time Frame: PK evaluations will be performed after 14 +/- 3 days of lisinopril therapy at 0 hour (pre-dose) 1, 2, 4, 5, 8, 12, and 24 hours post-lisinopril dose ] [ Designated as safety issue: No ]
- Area under the plasma concentration-time curve (AUC)
- Maximum observed concentration of drug in plasma (Cmax) and time of the maximum observed concentration in plasma (Tmax).
- Observed concentration prior to dose (C0h) and at the 24h post-dose pharmacokinetic sample (C24h).
- Apparent oral clearance (CL/F) and renal clearance (CLrenal).
Secondary Outcome Measures:
- Safety [ Time Frame: First dose of lisinopril to 30 days after last dose of study medication ] [ Designated as safety issue: Yes ]
- Additional PK data: lisinopril absorption rate (ka), oral apparent volume of distribution (V/F), influence on PK by demographic/ clinical covariates
- AEs during/after study drug administration by organ system
- Additional BP data: control per protocol clinic BPs, 24h ABPM, need for additional BP medications
- Exposure-response relationship: lisinopril plasma concentrations and BP (PK-PD model)
- Estimated glomerular filtration rate (eGFR) change
- Change in urinary protein excretion
- Non-Safety Secondary Outcome [ Time Frame: Dried Blood Spot (DBS) samples will be collected after 14 +/- 3 days of lisinopril therapy at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose ] [ Designated as safety issue: No ]Dried blood spot (DBS) sampling validity
- Non-Safety Secondary Outcome [ Time Frame: Iohexol GFR samples will be collected after 14 +/- 3 days of lisinopril therapy at intervals of 0, 2, 4, and 5 hours post-iohexol infusion ] [ Designated as safety issue: No ]eGFR and iohexol GFR relationship
| Estimated Enrollment: | 28 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Low Dose: Lisinopril
Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
|
Drug: Lisinopril
Lisinopril will be administered as a single oral dose at the following three dose levels: 0.1, 0.2, and 0.4 milligram per kilogram. The medication will be taken orally in suspension or tablet formulation once a day. Participants will receive study medication for 14±3 days.
|
|
Experimental: Medium Dose: Lisinopril
Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
|
Drug: Lisinopril
Lisinopril will be administered as a single oral dose at the following three dose levels: 0.1, 0.2, and 0.4 milligram per kilogram. The medication will be taken orally in suspension or tablet formulation once a day. Participants will receive study medication for 14±3 days.
|
|
Experimental: High Dose: Lisinopril
Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
|
Drug: Lisinopril
Lisinopril will be administered as a single oral dose at the following three dose levels: 0.1, 0.2, and 0.4 milligram per kilogram. The medication will be taken orally in suspension or tablet formulation once a day. Participants will receive study medication for 14±3 days.
|
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Kidney transplant recipient
- Age 2-17 years, inclusive, at the time of first study dose
- Estimated GFR (eGFR) ≥30 ml/min/1.73m2, with stable allograft function as indicated by <20% change in serum creatinine in the previous 30 days
- Stable immunosuppressive regimen, as indicated by <10% change in dosage (in mg/kg) in these medications, within the 14 days prior to enrollment
- Systolic BP >90th percentile for age, gender, and height, necessitating initiation or addition of an antihypertensive medication
- For females of child-bearing potential, a negative serum pregnancy test prior to initial dosing and agreement to practice appropriate contraceptive measures, including abstinence, from the time of the initial pregnancy testing through the remainder of the study (30 days after last administration of investigational agents).
Exclusion Criteria:
- History of anaphylaxis attributable to lisinopril or other ACEI agents (e.g., enalapril, ramipril, quinapril)
- History of anaphylaxis attributable to iohexol or an iodine hypersensitivity
- Use of an ACEI, angiotensin receptor blocker, or renin antagonist within 30 days prior to enrollment
- Stage 2 hypertension defined as the >99th percentile for age, height and gender + 5 mm Hg
- Blood Potassium value > 6.0 mEq/L (as determined at the screening visit)
- Previous participation in this study
- Physician concern that the participant may not adhere to the study protocol, based on prior behavior
- Current plasmapheresis treatment
- History of angioedema
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491919
Locations
| United States, Alabama | |
| University of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Daniel Feig, MD 205-939-6635 dfeig@uab.edu | |
| Contact: Stephanie Clevenger, RN 205-939-2792 | |
| United States, Arkansas | |
| Arkansas Children's Hospital | Recruiting |
| Little Rock, Arkansas, United States, 72202 | |
| Contact: Michelle Frost, RN, BSN 501-364-4490 frostm@archildrens.org | |
| United States, Georgia | |
| Emory University and Children's Healthcare of Atlanta | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Larry Greenbaum, MD 404-727-6994 lgreen6@emory.edu | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Debbie Gipson, MD 734-936-6997 dgipson@med.umich.edu | |
| United States, Missouri | |
| Children's Mercy Hospitals & Clinics | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Talita M Hill, RN,MSN,MBA-HCM,CCRC 816-234-3073 ext 53073 tmhill@cmh.edu | |
| United States, New York | |
| Albert Einstein University Hospital | Not yet recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Frederick Kaskel, MD 718-655-1120 fkaskel@aecom.yu.edu | |
| Contact: Patti Flynn, RN 718-655-1120 pflynn@montefiore.org | |
| New York University Langone Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Howard Trachtman, MD 646-501-2663 howard.trachtman@nyumc.org | |
| Contact: Suzanne Vento, RN 646-501-2665 suzanne.vento@nyumc.org | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Jens Goebel, MD 513-636-4531 jens.goebel@cchmc.org | |
Sponsors and Collaborators
Uptal Patel
Investigators
| Study Director: | Daniel Benjamin, MD, PhD, MPH | Duke University |
| Study Chair: | Howard Trachtman, MD | Cohen Children's Medical Center of New York |
| Principal Investigator: | Uptal D Patel, MD | Duke University |
More Information
Additional Information:
Publications:
| Responsible Party: | Uptal Patel, Assoc Professor of Medicine, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01491919 History of Changes |
| Other Study ID Numbers: | Pro00029537, HHSN275201000003I |
| Study First Received: | November 29, 2011 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Best Pharmaceuticals for Children Act(BPCA): Data Monitoring Committee |
Keywords provided by Duke University:
|
High Blood Pressure Hypertension Renal Transplantation Kidney Transplantation |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Lisinopril Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Cardiotonic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013