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Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients

ConditionChronic Kidney Failure in Children and Young Adults
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-39
SponsorUniversity Hospital Goettingen

About this trial

Recent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adolescents ≥ 10 to < 18 years with albuminuria (UACR ≥ 300mg/g creatinine) AND

eGFR ≥ 30 ml/min/1.73 m2 OR

adults ≥ 18 to < 40 years with albuminuria (UACR ≥ 500mg/g creatinine) AND

eGFR ≥ 60 ml/min/1.73 m2

Disqualifiers

Medical history that might limit the individual's ability to take trial treatments.

Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1.

eGFR<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation

Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin

    Drug

    Dapagliflozin (standard dose 10 mg p.o. once daily)

  • Placebo

    Drug

    Placebo (standard dose p.o. once daily)

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: DapagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary endpoint

Change from baseline urine albumin to creatinine ratio (UACR) after 48 weeks

Time frame
48 weeks

Secondary outcomes

1

Key secondary efficacy endpoint

Change from baseline estimated glomerular filtration rate (eGFR) after 52 weeks (4 weeks off treatment)

Time frame
52 weeks
2

Key secondary safety endpoint

Adverse events (including serious adverse events)

Time frame
52 weeks
3

Adverse events (AE) of special interest

(a) Ketoacidosis or symptomatic hypoglycemic event.

Time frame
52 weeks
4

Adverse events (AE) of special interest

(b) Hyperkalemia (potassium levels ≥15% of the upper normal limit)

Time frame
52 weeks

Other outcomes

Sponsors and contacts

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University Hospital Goettingen

Lead sponsor

German Research Foundation

Collaborator

Source ClinicalTrials.gov
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