Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant (PTN_LISINO)

Safety and Pharmacokinetics of Lisinopril in Pediatric Kidney Transplant Recipients

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Lisinopril

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University and Children's Healthcare of Atlanta
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • CHILDREN'S MERCY HOSPITALS & CLINICS
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Kidney transplant recipient
2. Age 2-17 years, inclusive, at the time of first study dose
3. 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
4. Stable immunosuppressive regimen, as indicated by <10% change in dosage (in mg/kg) in these medications, within the 14 days prior to enrollment
5. Systolic BP >90th percentile for age, gender, and height, necessitating initiation or addition of an antihypertensive medication
6. 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:

1. History of anaphylaxis attributable to lisinopril or other angiotensin-converting enzyme inhibitor (ACEI) agents (e.g.,enalapril, ramipril, quinapril)
2. History of anaphylaxis attributable to iohexol or an iodine hypersensitivity
3. Use of an angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker, or renin antagonist within 30 days prior to enrollment
4. Stage 2 hypertension defined as the >99th percentile for age, height and gender + 5 mm Hg
5. Blood Potassium value > 6.0 milliequivalent / liter (mEq/L) (as determined at the screening visit)
6. Previous participation in this study
7. Physician concern that the participant may not adhere to the study protocol, based on prior behavior
8. Current plasmapheresis treatment
9. History of angioedema
10. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low Dose: Lisinopril; Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day	Drug: Lisinopril; Subjects will be randomized to Low, Medium, or High dose of Lisinopril
EXPERIMENTAL: Medium Dose: Lisinopril; Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day	Drug: Lisinopril; Subjects will be randomized to Low, Medium, or High dose of Lisinopril
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; Subjects will be randomized to Low, Medium, or High dose of Lisinopril

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) - Area Under the Plasma Concentration-time Curve (AUC)	At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of AUC. Geometric mean was calculated from all measurements.	Day 14 (+/- 3 days) of lisinopril therapy at hours 0 (pre-dose) and 1,2,4,5,8,12 and 24 hrs after dose
PK - Maximum Observed Concentration of Drug in Plasma (Cmax)	At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of Cmax. Geometric mean was calculated from all measurements.	Day14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose
PK - Time of the Maximum Observed Concentration in Plasma (Tmax)	At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of plasma lisinopril concentration. Medium was calculated from all measurements.	Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose
PK - Oral Clearance (CL/F)	At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CL/F. Geometric mean was calculated from all measurements.	Day 14 (+/- 3 d) of dose at 0 hour and at 1, 2, 4, 5, 8, 12, and 24 hrs after dose
PK Renal Clearance (CLrenal)	At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CLrenal. Geometric mean was calculated from all measurements.	Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose.
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) During/After Study Drug Administration	Number of Adverse Events (AEs) related and not related to study drug; number of Serious Adverse Events (SAEs) related and not related to study drug	First dose of study drug to 30 days after final study visit for AEs and until resolution for SAEs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Potassium Level From Baseline in Lisinopril-naive Participants	Potassium values will be obtained at Baseline and Day 14 prior to the final dose of study drug. Mean calculated from the two measurements.	At baseline visit and Day 14 prior to final study dose.
Worse Post-dose Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline in Lisinopril-naive Participants	The eGFR at entry will need to be ≥ 30 ml/min/1.73m^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitors (ACE-I)-mediated reduction in kidney function. eGFR ratio was computed from the worst post-dose value divided by the Baseline value.	Baseline to Day 14 (+/- 3 days)
Largest eGFR Percent Decrease From Baseline in Lisinopril-naive Participants	The eGFR at entry will need to be ≥ 30 ml/min/1.73m^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitor (ACEI) mediated reduction in kidney function. Largest eGFR percent decrease from baseline reported in results section.	Baseline to Day 14 (+/- 3 days)
Change in Urine Protein/Creatinine From Baseline in Lisinopril-naive Participants.	Change in urine protein/creatinine obtained as follows: Mean change (worst post-dose from baseline) presented for urine protein/creatinine ratio. Geometric mean of the ratio (worst post-dose / baseline with Geometric Coefficient of Variation percent (CV%) and greatest decrease presented for eGFR by dose group. Two patients in the high dose group had an evaluable urine protein/creatinine change.	Baseline to worst post-dose before Day 14 (+/- 3 days)
Change in Diastolic Blood Pressure From Baseline in Lisinopril-naive Participants	Ambulatory blood pressure readings were measured during the baseline/pre-study dose period using a SpaceLabs (Redmond, WA) device at home to avoid the confounding effects of venipuncture and abnormal sleep pattern. Another blood pressure reading was performed at 1 day before the final dose of lisinopril (day before the last scheduled visit). The mean of these measurements was calculated.	Baseline to Day 14 (+/-3 days)
Change in Systolic Blood Pressure From Baseline in Lisinopril-naive Participants	Ambulatory blood pressure readings were measured during the baseline/pre-study dose period using a SpaceLabs (Redmond, WA) device at home to avoid the confounding effects of venipuncture and abnormal sleep pattern. Another blood pressure reading was performed at 1 day before the final dose of lisinopril (day before the last scheduled visit). The mean from these measurements was calculated.	Baseline to Day 14 (+/- 3 days)
Change in Systolic Blood Pressure (BP) From Baseline in Lisinopril SOC Group	Lisinopril SOC participants were not given the ambulatory blood pressure machine to obtain readings at home, as was the Lisinopril-naive participants. Instead BP measurements were obtained during screening visit and compared to the Day 14 to 40 visit measurements. Note: these participants were not required to attend a Day 14 (+/-3 day visit) but did need to attend sometime between Day 14 to Day 40 (inclusive). The mean of these blood pressure measurements was calculated.	Screening to Day 14 to 40
Change in Diastolic Blood Pressure From Baseline in Lisinopril SOC Group	Lisinopril SOC participants were not given the ambulatory blood pressure machine to obtain readings at home, as was the Lisinopril-naive participants. Instead BP measurements were obtained during screening visit and compared to the Day 14 to 40 visit measurements (note: the participants were not required to attend a Day 14 (+/-3 day visit) but did need to attend sometime between Day 14 to Day 40. The mean from the blood pressure measurements was calculated.	Screening to Day 14 to 40

Collaborators and Investigators

• Sponsor: Uptal Patel
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Rochester; The Emmes Company, LLC; OpAns, LLC
• Investigators: Study Director: Daniel Benjamin, MD, PhD, MPH, Duke University; Study Chair: Howard Trachtman, MD, NYU Langone Health; Principal Investigator: Uptal D Patel, MD, Duke University

Publications and helpful links

General Publications

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• National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76. No abstract available.
• Knutter I, Wollesky C, Kottra G, Hahn MG, Fischer W, Zebisch K, Neubert RH, Daniel H, Brandsch M. Transport of angiotensin-converting enzyme inhibitors by H+/peptide transporters revisited. J Pharmacol Exp Ther. 2008 Nov;327(2):432-41. doi: 10.1124/jpet.108.143339. Epub 2008 Aug 19.
• Lin JH, Chen IW, Ulm EH, Duggan DE. Differential renal handling of angiotensin-converting enzyme inhibitors enalaprilat and lisinopril in rats. Drug Metab Dispos. 1988 May-Jun;16(3):392-6.
• Hogg RJ, Delucchi A, Sakihara G, Wells TG, Tenney F, Batisky DL, Blumer JL, Vogt BA, Lo MW, Hand E, Panebianco D, Rippley R, Shaw W, Shahinfar S. A multicenter study of the pharmacokinetics of lisinopril in pediatric patients with hypertension. Pediatr Nephrol. 2007 May;22(5):695-701. doi: 10.1007/s00467-006-0399-5. Epub 2007 Jan 10.
• Prinivil® (lisinopril tablets) package insert; Whitehouse Station, NJ: Merck & Co., Inc.; 2003
• Mitsnefes MM, Khoury PR, McEnery PT. Early posttransplantation hypertension and poor long-term renal allograft survival in pediatric patients. J Pediatr. 2003 Jul;143(1):98-103. doi: 10.1016/S0022-3476(03)00209-9.
• Silverstein DM, Leblanc P, Hempe JM, Ramcharan T, Boudreaux JP. Tracking of blood pressure and its impact on graft function in pediatric renal transplant patients. Pediatr Transplant. 2007 Dec;11(8):860-7. doi: 10.1111/j.1399-3046.2007.00753.x.
• Mitsnefes MM, Omoloja A, McEnery PT. Short-term pediatric renal transplant survival: blood pressure and allograft function. Pediatr Transplant. 2001 Jun;5(3):160-5. doi: 10.1034/j.1399-3046.2001.t01-1-00051.x.
• Cross NB, Webster AC, Masson P, O'connell PJ, Craig JC. Antihypertensives for kidney transplant recipients: systematic review and meta-analysis of randomized controlled trials. Transplantation. 2009 Jul 15;88(1):7-18. doi: 10.1097/TP.0b013e3181a9e960.
• Sorof JM, Goldstein SL, Brewer ED, Steiger HM, Portman RJ. Use of anti-hypertensive medications and post-transplant renal allograft function in children. Pediatr Transplant. 2000 Feb;4(1):21-7. doi: 10.1034/j.1399-3046.2000.00082.x.
• Hernandez AA, Moreso F, Bayes B, Lauzurica R, Sanz-Guajardo D, Gomez-Huertas E, Pereira P, Paul J, Crespo J, Amenabar JJ, Oliver J, Seron D. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in renal transplantation between 1990 and 2002 in Spain. NDT Plus. 2010 Jun;3(Suppl_2):ii21-ii25. doi: 10.1093/ndtplus/sfq068.
• Mitterbauer C, Heinze G, Kainz A, Kramar R, Horl WH, Oberbauer R. ACE-inhibitor or AT2-antagonist therapy of renal transplant recipients is associated with an increase in serum potassium concentrations. Nephrol Dial Transplant. 2008 May;23(5):1742-6. doi: 10.1093/ndt/gfm864. Epub 2008 Jan 30.
• Hiremath S, Fergusson D, Doucette S, Mulay AV, Knoll GA. Renin angiotensin system blockade in kidney transplantation: a systematic review of the evidence. Am J Transplant. 2007 Oct;7(10):2350-60. doi: 10.1111/j.1600-6143.2007.01928.x.
• Morath C, Schmied B, Mehrabi A, Weitz J, Schmidt J, Werner J, Buchler MW, Morcos M, Nawroth PP, Schwenger V, Doehler B, Opelz G, Zeier M. Angiotensin-converting enzyme inhibitors and angiotensin II type 1 receptor blockers after renal transplantation. Clin Transplant. 2009 Dec;23 Suppl 21:33-6. doi: 10.1111/j.1399-0012.2009.01107.x.
• Inigo P, Campistol JM, Lario S, Piera C, Campos B, Bescos M, Oppenheimer F, Rivera F. Effects of losartan and amlodipine on intrarenal hemodynamics and TGF-beta(1) plasma levels in a crossover trial in renal transplant recipients. J Am Soc Nephrol. 2001 Apr;12(4):822-827. doi: 10.1681/ASN.V124822.
• Nielsen SE, Schjoedt KJ, Astrup AS, Tarnow L, Lajer M, Hansen PR, Parving HH, Rossing P. Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Kidney Injury Molecule 1 (KIM1) in patients with diabetic nephropathy: a cross-sectional study and the effects of lisinopril. Diabet Med. 2010 Oct;27(10):1144-50. doi: 10.1111/j.1464-5491.2010.03083.x.
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• CDER Approval Package for Prinivil®: Application Number 19-558/S-043. Clinical Pharmacology and Biopharmaceutics Review. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-558S043_Prinivil.cfm. Last accessed Jan. 6, 2011.
• Rhodin MM, Anderson BJ, Peters AM, Coulthard MG, Wilkins B, Cole M, Chatelut E, Grubb A, Veal GJ, Keir MJ, Holford NH. Human renal function maturation: a quantitative description using weight and postmenstrual age. Pediatr Nephrol. 2009 Jan;24(1):67-76. doi: 10.1007/s00467-008-0997-5. Epub 2008 Oct 10.
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• Sayed-Tabatabaei FA, Oostra BA, Isaacs A, van Duijn CM, Witteman JC. ACE polymorphisms. Circ Res. 2006 May 12;98(9):1123-33. doi: 10.1161/01.RES.0000223145.74217.e7.
• Wuhl E, Witte K, Soergel M, Mehls O, Schaefer F; German Working Group on Pediatric Hypertension. Distribution of 24-h ambulatory blood pressure in children: normalized reference values and role of body dimensions. J Hypertens. 2002 Oct;20(10):1995-2007. doi: 10.1097/00004872-200210000-00019. Erratum In: J Hypertens. 2003 Nov;21(11):2205-6.
• Soergel M, Kirschstein M, Busch C, Danne T, Gellermann J, Holl R, Krull F, Reichert H, Reusz GS, Rascher W. Oscillometric twenty-four-hour ambulatory blood pressure values in healthy children and adolescents: a multicenter trial including 1141 subjects. J Pediatr. 1997 Feb;130(2):178-84. doi: 10.1016/s0022-3476(97)70340-8.
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Helpful Links

• Pediatric Trials Network (PTN)
• The Eunice Kennedy Shriver National Institute of Child Health and Human
• Information about Lisinopril

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: November 29, 2011
• First Submitted That Met QC Criteria: December 12, 2011
• First Posted (ESTIMATE): December 14, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2015
• Last Update Submitted That Met QC Criteria: June 15, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Renal Transplantation; Hypertension; Kidney Transplantation; High Blood Pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Protective Agents; Cardiotonic Agents; Angiotensin-Converting Enzyme Inhibitors; Lisinopril
• Other Study ID Numbers: Pro00029537; HHSN275201000003I (Other Identifier: National Institute of Child Health & Human Development)