Safety of tenofovir alafenamide (TAF) in patients who developed kidney toxicity while receiving tenofovir disoproxil fumarate (TDF)

Safety of tenofovir alafenamide (TAF) in patients with a history of tubulopathy on tenofovir disoproxil fumarate (TDF) - FANCONI-TAF (FANTA) study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003345-29-GB

Enrollment

Registered

2016-11-15

Start date

2016-11-16

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Descovy Pharmaceutical Form: Film-coated tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: Descovy Pharmaceutical Form: Film-coate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects must meet all the following inclusion criteria to be eligible for participation in this study • Age = 16 years • Documented HIV-1 antibody test • Able to give informed consent • Documented history of TDF-induced acute tubular injury on renal biopsy which was not explained by other factors, or TDF-induced treatment-limiting tubulopathy, defined by at least 2 of the following: o Proteinuria of =1+ on urinary dipstick (or protein/creatinine ratio >30 mg/mmol) o Glycosuria of =1+ on urinary dipstick o Serum phosphate 5 mL/min/1.73m2/year with >25% reduction from baseline) • On stable antiretroviral therapy for preceding 6 months • HIV RNA =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Subjects who meet any of the exclusion criteria must not be enrolled in the study Diabetes mellitus Dipstick glucose =1+ at screening or baseline Dipstick proteinuria >2+ or urine protein-creatinine ratio =100 mg/mmol at screening or baseline Estimated glomerular filtration rate (eGFR) grade 3 (ACTG criteria) Current alcohol use (>3 units daily for the past month) or drug dependence which would make the participant unable to comply with the protocol (investigator opinion) Significant co-morbidities (investigator opinion) Current use of rifamycins (rifampicin or rifabutin) Individuals unable or unwilling to comply with the requirements of the study (investigator opinion)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the renal and bone safety of TAF in patients with a history of tubulopathy/Fanconi syndrome while receiving TDF Primary endpoint •Between study arm difference in change from baseline to week 12 in retinol-binding protein/creatinine ratio (RBPCR) Secondary endpoints •Incidence of tubulopathy in the TAF/FTC exposed population (through week 96) •Between study arm difference in change from baseline in: oRenal function and bone turnover markers (week 4, 12) •Change from baseline in the TAF/FTC exposed population: oRenal function and bone turnover markers (week 24, 48, 72, 96) oBone mineral density (week 48, 96) ;Secondary Objective: N/A;Primary end point(s): Between study arm difference in the change from baseline to week 12 in retinol-binding protein/creatinine ratio (RBPCR). ;Timepoint(s) of evaluation of this end point: Between baseline and week 12	—

Measure

Time frame

Main Objective: To evaluate the renal and bone safety of TAF in patients with a history of tubulopathy/Fanconi syndrome while receiving TDF Primary endpoint •Between study arm difference in change from baseline to week 12 in retinol-binding protein/creatinine ratio (RBPCR) Secondary endpoints •Incidence of tubulopathy in the TAF/FTC exposed population (through week 96) •Between study arm difference in change from baseline in: oRenal function and bone turnover markers (week 4, 12) •Change from baseline in the TAF/FTC exposed population: oRenal function and bone turnover markers (week 24, 48, 72, 96) oBone mineral density (week 48, 96) ;Secondary Objective: N/A;Primary end point(s): Between study arm difference in the change from baseline to week 12 in retinol-binding protein/creatinine ratio (RBPCR). ;Timepoint(s) of evaluation of this end point: Between baseline and week 12

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Secondary

Measure	Time frame
Secondary end point(s): Between study arm differences in changes from baseline in: o Estimated glomerular filtration rate (eGFR-CKD-Epi) based on plasma creatinine and cystatin C, fractional excretion of phosphate, fractional excretion of uric acid, fractional excretion of urea, fasting plasma osmolarity, fasting urine osmolarity at weeks 4 and 12 o Urine albumin/creatinine ratio (ACR), protein/creatinine ratio (PCR), cystatin C/creatinine ratio (CCR), renal phosphate threshold (TmPO4), at weeks 4 and 12 and RBPCR at week 4 o Alkaline phosphatase (ALP), carboxy-terminal collagen crosslinks (CTx), procollagen type 1 N propeptide (P1NP) and parathyroid hormone (PTH) at week 12 • Incidence of tubulopathy (Fanconi syndrome) in the TAF/FTC exposed population (through 5 years), and changes from baseline in: o eGFR-creatinine and eGFR-cystatin C at weeks 4, 12, 24, 48 and 96, and year 3, 4 and 5 o ACR, PCR, RBPCR and fractional excretion of phosphate at weeks 4, 12, 24, 48 and 96, and at year 3, 4 and 5 o ALP, CTx, P1NP, vitamin D (25[OH]D) and PTH at weeks 24, 48 and 96, and at year 3, 4 and 5. Bone mineral density (BMD) of the femoral neck, total hip and lumbar spine at weeks 48 and 96, and year 5. ;Timepoint(s) of evaluation of this end point: Between baseline at weeks 24, 48 and 96, and at year 3, 4 and 5.	—

Measure

Time frame

Secondary end point(s): Between study arm differences in changes from baseline in: o Estimated glomerular filtration rate (eGFR-CKD-Epi) based on plasma creatinine and cystatin C, fractional excretion of phosphate, fractional excretion of uric acid, fractional excretion of urea, fasting plasma osmolarity, fasting urine osmolarity at weeks 4 and 12 o Urine albumin/creatinine ratio (ACR), protein/creatinine ratio (PCR), cystatin C/creatinine ratio (CCR), renal phosphate threshold (TmPO4), at weeks 4 and 12 and RBPCR at week 4 o Alkaline phosphatase (ALP), carboxy-terminal collagen crosslinks (CTx), procollagen type 1 N propeptide (P1NP) and parathyroid hormone (PTH) at week 12 • Incidence of tubulopathy (Fanconi syndrome) in the TAF/FTC exposed population (through 5 years), and changes from baseline in: o eGFR-creatinine and eGFR-cystatin C at weeks 4, 12, 24, 48 and 96, and year 3, 4 and 5 o ACR, PCR, RBPCR and fractional excretion of phosphate at weeks 4, 12, 24, 48 and 96, and at year 3, 4 and 5 o ALP, CTx, P1NP, vitamin D (25[OH]D) and PTH at weeks 24, 48 and 96, and at year 3, 4 and 5. Bone mineral density (BMD) of the femoral neck, total hip and lumbar spine at weeks 48 and 96, and year 5. ;Timepoint(s) of evaluation of this end point: Between baseline at weeks 24, 48 and 96, and at year 3, 4 and 5.

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Countries

United Kingdom

Contacts

Public ContactDr Frank Post

Kings College Hospital NHS Foundation Trust

frank.post@kcl.ac.uk442078485779

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 15, 2026