Drug TransporterPhase 4NCT03710395
Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk.
A Phase 4 study testing Blood and breast milk sampling and Nifedipine in people with Drug Transporter, run by Natalia Valadares de Moraes.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Transporter
- What is being tested?
- Blood and breast milk sampling and Nifedipine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2015to 1 Oct 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chronic hypertensive breastfeeding women
- Patients being treated with 20 mg slow-release nifedipine every 12 hours for at least 15 days
Who cannot join
- 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.
About this study
Official title: Influence of Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk in Hypertensive Breastfeeding Women.
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.
Read the 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.
- Conditions
- Drug Transporter
- Being tested
- Blood and breast milk sampling, Nifedipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and breast milk samplingProcedure or surgery
Also called Biological samples for nifedipine analysis
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.
NifedipineDrug
Also called 20 mg nifedipine (slow-release)
Chronic hypertensive breastfeeding women will be treated with slow-release 20 mg nifedipine, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Wild homozygous for ABCG2 c.421C>A | Active comparator | Chronic hypertensive breastfeeding women (18-45 years old) genotyped as wild homozygous for ABCG2 c.421C>A. Receives: Procedure: Blood and breast milk sampling; Drug: Nifedipine |
| Variant genotypes for ABCG2 c.421C>A | Experimental | Chronic hypertensive breastfeeding women (18-45 years old) genotyped as heterozygous or mutant homozygous for ABCG2 c.421C>A. Receives: Procedure: Blood and breast milk sampling; Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nifedipine concentration in plasma/milk ratio
The concentration ratio will be determined as (nifedipine concentration in plasma)/(nifedipine concentration in breast milk).
Measured: After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning.
Secondary outcomes (2)
Nifedipine concentration in plasma
The concentration of nifedipine in plasma determined by HPLC.
Measured: After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning.
Nifedipine concentration in milk
The concentration of nifedipine in breast milk determined by HPLC.
Measured: After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start14 Dec 2015
- Primary completion1 Feb 2018
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug TransporterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natalia Valadares de Moraes
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital das Clínicas de Ribeirão Preto
- Responsible party
- Sponsor-investigator, Natalia Valadares de Moraes, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710395
- Sponsor's protocol ID
- NIFEDABCG2BCRP
- Status last verified
- Oct 2018
- First submitted
- 17 Jul 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk in Hypertensive Breastfeeding Women.
- ClinicalTrials.gov ID
- NCT03710395
- Acronym / sponsor ID
- NIFEDABCG2BCRP
- Conditions
- Drug Transporter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Natalia Valadares de MoraesUniversity, hospital or other
- Collaborators
- Hospital das Clínicas de Ribeirão Preto
- Study start
- 14 Dec 2015 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wild homozygous for ABCG2 c.421C>A | Active comparator | Procedure: Blood and breast milk sampling, Drug: NifedipineChronic hypertensive breastfeeding women (18-45 years old) genotyped as wild homozygous for ABCG2 c.421C>A. |
| Variant genotypes for ABCG2 c.421C>A | Experimental | Procedure: Blood and breast milk sampling, Drug: NifedipineChronic hypertensive breastfeeding women (18-45 years old) genotyped as heterozygous or mutant homozygous for ABCG2 c.421C>A. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic hypertensive breastfeeding women
- Patients being treated with 20 mg slow-release nifedipine every 12 hours for at least 15 days
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and breast milk samplingAlso: Biological samples for nifedipine analysisAt 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. | Procedure or surgery | Variant genotypes for ABCG2 c.421C>A, Wild homozygous for ABCG2 c.421C>A |
| NifedipineAlso: 20 mg nifedipine (slow-release)Chronic hypertensive breastfeeding women will be treated with slow-release 20 mg nifedipine, twice a day. | Drug | Variant genotypes for ABCG2 c.421C>A, Wild homozygous for ABCG2 c.421C>A |
Primary outcome
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).
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood and breast milk sampling and Nifedipine in people with Drug Transporter, run by Natalia Valadares de Moraes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.