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Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk.

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ClinicalTrials.gov Identifier: NCT03710395
Recruitment Status : Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
Hospital das Clínicas de Ribeirão Preto
Information provided by (Responsible Party):
Natalia Valadares de Moraes, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary:
This study aims to investigate the influence of the c.421C>A genetic polymorphism of the ABCG2 / BCRP transporter in the concentration ratio of nifedipine in maternal milk:plasma in hypertensive breastfeeding women attended at the Gynecology and Obstetrics Service of the Medical School of Ribeirão Preto, of the University of São Paulo. Thus, plasma and breast milk samples are being collected from patients in chronic use of the drug (n=30) within 15 to 30 days postnatal.

Condition or disease Intervention/treatment Phase
Drug Transporter Procedure: Blood and breast milk sampling Drug: Nifedipine Phase 4

Detailed Description:
The breast cancer resistance protein (ABCG2/BCRP) human transporter, encoded by the ABCG2 gene, is highly expressed on the human lactating breast. Nifedipine, a known substrate of ABCG2, is used for the treatment of hypertension in pregnancy and during breastfeeding. ABCG2 plays an important role on secreting drugs and xenobiotics into milk. The aim of the present study was to evaluate the effect of ABCG2 c.421C>A on nifedipine breast milk/plasma concentration ratio in hypertensive breastfeeding women. Nineteen hypertensive breastfeeding women treated with 20 mg slow-release nifedipine every 12 hours were investigated. Blood and breast milk samples were collected simultaneously 15-30 days after delivery and at least 15 days after drug treatment, in order to reach drug steady state. All patients were genotyped for ABCG2 c.421C>A using real time-PCR. Nifedipine concentration was determined in plasma and breast milk by high-performance liquid chromatography using UV detection. The comprehension of the variability in the transport of nifedipine to breast milk in hypertensive breastfeeding women will contribute to the evaluation of drug exposure in breast-fed infants to nifedipine and other ABCG2 substrates.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk in Hypertensive Breastfeeding Women.
Actual Study Start Date : December 14, 2015
Actual Primary Completion Date : February 1, 2018
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
Drug Information available for: Nifedipine

Arm Intervention/treatment
Active Comparator: Wild homozygous for ABCG2 c.421C>A
Chronic hypertensive breastfeeding women (18-45 years old) genotyped as wild homozygous for ABCG2 c.421C>A.
Procedure: Blood and breast milk sampling
At least 15 days after starting treatment with 20 mg slow-release nifedipine every 12 hours. Blood and breast milk will be sampled before first dosing in the morning.
Other Name: Biological samples for nifedipine analysis

Drug: Nifedipine
Chronic hypertensive breastfeeding women will be treated with slow-release 20 mg nifedipine, twice a day.
Other Name: 20 mg nifedipine (slow-release)

Experimental: Variant genotypes for ABCG2 c.421C>A
Chronic hypertensive breastfeeding women (18-45 years old) genotyped as heterozygous or mutant homozygous for ABCG2 c.421C>A.
Procedure: Blood and breast milk sampling
At least 15 days after starting treatment with 20 mg slow-release nifedipine every 12 hours. Blood and breast milk will be sampled before first dosing in the morning.
Other Name: Biological samples for nifedipine analysis

Drug: Nifedipine
Chronic hypertensive breastfeeding women will be treated with slow-release 20 mg nifedipine, twice a day.
Other Name: 20 mg nifedipine (slow-release)




Primary Outcome Measures :
  1. Nifedipine concentration in plasma/milk ratio [ Time Frame: After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning. ]
    The concentration ratio will be determined as (nifedipine concentration in plasma)/(nifedipine concentration in breast milk).


Secondary Outcome Measures :
  1. Nifedipine concentration in plasma [ Time Frame: After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning. ]
    The concentration of nifedipine in plasma determined by HPLC.

  2. Nifedipine concentration in milk [ Time Frame: After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning. ]
    The concentration of nifedipine in breast milk determined by HPLC.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chronic hypertensive breastfeeding women
  • Patients being treated with 20 mg slow-release nifedipine every 12 hours for at least 15 days

Exclusion Criteria:

  • Patients in use of ABCG2 inhibitors (omeprazole, pantoprazole, ritonavir, saquinavir, imatinib, efavirenz, nicardipine, abacavir, tacrolimus, ciclosporin A, cannabidiol);
  • Patients who presented nifedipine adverse drug reactions
  • Patients whose blood pressure normalized after delivery
  • Patients who interrupted breastfeeding during the study
  • Patients who did not return to the hospital for the clinical protocol.

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Responsible Party: Natalia Valadares de Moraes, Professor of Toxicology, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03710395     History of Changes
Other Study ID Numbers: NIFEDABCG2BCRP
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents