HARMONY-Follow-up-Study (Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients)

HARMONY-Follow-up-Study (Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients) - HARMONY-Follow-up

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005786

Enrollment

500

Registered

2014-03-10

Start date

2014-03-04

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Z94.0

Interventions

Group 1: In this study the intervention arms of the HARMONY study will be proved again, there will be no new intervention: Intervention arm A: Standard: Advagraf, CellCept, Decortin H + 2xSimulect day

Eligibility

Sex/Gender

All

Age

18 Years to 83 Years

Inclusion criteria

Inclusion criteria: Patients with kidney transplantation and taking part at the HARMONY-study patients with a signed informed consent form

Exclusion criteria

Exclusion criteria: Patient who are not able to realize nature, relevance and consequences of the clinical trial and who are not able to comply, to cooperate and communicate adequately and to follow the instructions of the study or even to give their informed consent

Design outcomes

Primary

Measure	Time frame
rate and severity of acute bioptical confirmed rejections (Banff) time to the first bioptical verified rejection	—

Secondary

Measure	Time frame
rate of patients with steroid-free immunosuppression patient and graft survival rate graft function (calculated by the Cock- croft-Gault and MDRD-IV formula respectively calculated creatinine clearance by the Nankivell formula respectively cystatin C measurement) number of steroid-resistant rejections blood pressure level and also amount and types of blood pressure medications lipid levels and also amount and types of lipid-lowering medications body weight, relative weight gain [kg], BMI infection rate, infection type and infection severity anaemia requiering erythropoetin treatment PTLD incidence tumor incidence incidence of diabetes mellitus (ADA, venous fasting blood sugar >=7,0 mmol/L, pathological oGTT) and incidence of abnormal fasting blood sugar levels respectively of impaired glucose tolerance, incidence of a de novo insulin-requiriring or oral-antidiabetic-requiring treatment over >= 30 days incidence of cataracts incidence of avascular necrosis incidence of osteoporosis (assessment of fracture rate and osteodensiometry) wound healing disorders incidence of chronic allograft nephropathy (CAN) with histology incidence of CMV-disease (qPCR > 400 copies/µl) incidence of BKV-disease (qPCR >10000 copies/µl)	—

Measure

Time frame

rate of patients with steroid-free immunosuppression patient and graft survival rate graft function (calculated by the Cock- croft-Gault and MDRD-IV formula respectively calculated creatinine clearance by the Nankivell formula respectively cystatin C measurement) number of steroid-resistant rejections blood pressure level and also amount and types of blood pressure medications lipid levels and also amount and types of lipid-lowering medications body weight, relative weight gain [kg], BMI infection rate, infection type and infection severity anaemia requiering erythropoetin treatment PTLD incidence tumor incidence incidence of diabetes mellitus (ADA, venous fasting blood sugar >=7,0 mmol/L, pathological oGTT) and incidence of abnormal fasting blood sugar levels respectively of impaired glucose tolerance, incidence of a de novo insulin-requiriring or oral-antidiabetic-requiring treatment over >= 30 days incidence of cataracts incidence of avascular necrosis incidence of osteoporosis (assessment of fracture rate and osteodensiometry) wound healing disorders incidence of chronic allograft nephropathy (CAN) with histology incidence of CMV-disease (qPCR > 400 copies/µl) incidence of BKV-disease (qPCR >10000 copies/µl)

—

Countries

Germany

Contacts

Public ContactOliver Thomusch

Universitätsklinikum Freiburg, Allgemein- und Viszeralchirurgie

oliver.thomusch@uniklinik-freiburg.de+49 761 270-28580

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 5, 2026